Dalaclin

Quick links to important sections

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Dalaclin

Property Description
Active ingredient Clindamycin Phosphate
Form Topical Solution or Gel
Pharmacological class Lincosamide Antibiotic
General purpose Management of bacterial skin infections
Origin Synthetic Derivative

What Type of Medicine is Dalaclin?

Dalaclin is a focused dermatological drug that contains the active ingredient Clindamycin Phosphate, and is fundamentally classified as a Lincosamide antibiotic. This agent is primarily employed for its potent antibacterial agent activity, which is clinically recognized for controlling the proliferation of susceptible bacteria on the skin. The compound acts as a key protein synthesis inhibitor within bacteria. This function means the medicine actively hinders the growth of susceptible microorganisms. As a synthetic compound, Clindamycin Phosphate is chemically derived from the parent antibiotic Lincomycin, undergoing modification to create the compound 7-chloro-7-deoxylincomycin. This specific formulation positions Dalaclin as a prescription-only medicine, typically designated for adolescents and adults.

Dalaclin's Formulation and General Therapeutic Purpose

Dalaclin is manufactured as a targeted topical preparation, typically supplied either as a topical solution or a gel, enabling a focused topical route of administration directly to the affected skin surface. The core general therapeutic purpose of this formulation is to manage bacterial infections by targeting and controlling the growth of specific bacteria, such as Propionibacterium acnes, often implicated in the pathology of the skin. For example, Dalaclin is commonly used in scenarios where localized bacterial overgrowth contributes to inflammatory lesions. By exerting a bacteriostatic action, the medicine helps to limit microbial proliferation, which is integral to the overall benefit of alleviating the infectious component of conditions like acne vulgaris. This approach provides localized microbial control without involving systemic drug exposure, based on its localized absorption profile.

What side effects are possible with Dalaclin?

The official safety documentation for Dalaclin, which contains Clindamycin Phosphate, focuses on classifying expected skin reactions and detailing the potential for serious gastrointestinal concerns.

Adverse Reactions by Frequency and System

Adverse reactions are primarily localized to the skin, but the systemic risk involves the digestive tract. Clinical trials classify effects based on frequency:

  • Very Common (≥ 10%): Application site dryness.
  • Common (1% to < 10%): Application site burning, itching, erythema (redness), peeling, and oily skin.

Other less frequent reactions include contact dermatitis, abdominal pain, and gram-negative folliculitis. The alcohol base in some topical solutions may cause burning and irritation upon accidental contact with sensitive surfaces like the eyes or broken skin.

Serious Safety Considerations

Although Dalaclin is applied topically, a major safety warning addresses the risk of colitis, including pseudomembranous colitis, which has been reported rarely due to systemic absorption. This can manifest as severe diarrhea, potentially bloody diarrhea, and abdominal cramps. This serious gastrointestinal concern may develop even several weeks after treatment has stopped.

Contraindications and Special Populations

Dalaclin is formally contraindicated in individuals with a known history of hypersensitivity to clindamycin or lincomycin, or a history of specific bowel conditions like regional enteritis or antibiotic-associated colitis. Special caution is noted for atopic individuals. For pregnant women, use during the first trimester is generally limited to when clearly necessary. Clindamycin has been reported to appear in breast milk, carrying the potential to affect the nursing infant's gastrointestinal flora.

Overdose and Emergency Response

The official regulatory documents indicate that Dalaclin (Clindamycin Phosphate Topical Solution/Gel) can be absorbed through the skin in amounts sufficient to produce systemic effects. While rare with topical use, this systemic absorption carries a documented risk of developing colitis, including pseudomembranous colitis. This is classified as a potentially severe outcome that has, in some cases, been associated with mortality, linking the topical agent's systemic potential to the known risks of the lincosamide class.

Manifestations of this systemic effect may include severe persistent diarrhea, bloody diarrhea, and intense abdominal cramps. Symptoms may be delayed, sometimes appearing weeks after therapy has ended. In the event of suspected systemic overdosage or if severe gastrointestinal symptoms develop, emergency medical attention must be sought immediately, as required by regulatory guidance. For such cases, general symptomatic and supportive measures are indicated. The official documentation notes that diagnostic procedures such as endoscopy or testing for Clostridium difficile toxin may be required to confirm the diagnosis.

For accidental exposure of the product to the eyes or other sensitive surfaces, which may cause burning and irritation, the regulatory instruction is to immediately bathe the affected area with copious amounts of cool tap water.

Therapeutic Uses of Dalaclin

What Dalaclin Treats: Main Uses and Benefits

Dalaclin is used in therapeutic settings involving certain distressing symptoms associated with skin conditions, specifically acne vulgaris. The medicine is considered relevant for this condition, particularly in instances characterized by periods of heightened symptoms, helping to address symptom clusters that may become intense or disruptive. The medication is commonly used to help manage the symptoms of mild to moderate inflammatory acne, used in situations involving symptoms related to inflammatory or irritative states, such as red, raised papules and pustules.

The medicine is applied across domains where additional symptomatic support is needed, targeting the bacterial component associated with these inflammatory or irritative states. It offers symptomatic relief that helps patients cope more steadily with these difficult manifestations, particularly in adolescents and adults experiencing recurrent inflammatory episodes.


Quick Fact: Relief for Inflammatory Symptoms

Quick Fact: Relief for Inflammatory Symptoms Dalaclin is commonly used in clinical settings that involve acute or unstable symptom patterns, providing supportive relief when symptoms interfere with routine activities. It assists with maintaining functional stability and contributes to easing the overall symptom load during active breakouts.

Regulatory References

  1. DailyMed official labeling for Clindamycin Phosphate Topical Solution

Eligibility and Restrictions for Use

Eligibility for Dalaclin (Clindamycin Topical) Defined by Regulatory Documents

Contraindicated Populations (Must Not Use)

Dalaclin is strictly contraindicated in patients with a history of hypersensitivity to the active ingredient clindamycin or the related drug lincomycin. Use is also prohibited in individuals with a history of specific severe gastrointestinal diseases, including regional enteritis, ulcerative colitis, or antibiotic-associated colitis (e.g., pseudomembranous colitis).

Age and Physiological Restrictions

The safety and effectiveness of Dalaclin have not been established in children under 12 years of age, and its use is therefore not recommended for this population. Effectiveness is established for adolescents 12 years and older and adults. Pregnant women in the first trimester should use the medicine only if clearly needed. For nursing mothers, official labeling mandates a decision be made to discontinue either nursing or the drug itself.

Conditional Use (Caution Required)

The medicine should be used with caution in atopic individuals and in patients who are concurrently receiving neuromuscular blocking agents.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes the officially documented interaction patterns for Dalaclin, based on government regulatory labeling, which are primarily related to pharmacodynamic effects and local application constraints.

Drug-Drug and Systemic Interactions

Co-administration with certain systemic medicines has documented risks. Concurrent use with antibiotics containing Erythromycin is generally not recommended because regulatory documents describe a potential pharmacodynamic antagonism. This interaction arises from competitive action at the bacterial ribosomal subunit, which may reduce the antibacterial effect. A second area of official restriction involves Neuromuscular Blocking Agents (NMBAs). Systemic absorption of Clindamycin can contribute to an enhanced neuromuscular blockade when used alongside agents such as atracurium, rocuronium, or vecuronium, a pattern noted in the prescribing information. Furthermore, the medicine is formally contraindicated in individuals with a known history of hypersensitivity to the related compound Lincomycin due to cross-sensitivity.

Topical and Local Interactions

The official labeling notes constraints regarding local use with other topical products. Co-application with other medicines intended for acne that contain ingredients like salicylic acid, sulfur, tretinoin, or benzoyl peroxide may cause a cumulative irritant effect, leading to excessive drying or peeling of the skin. Similarly, use with topical preparations containing a high concentration of alcohol, such as astringents or toners, can lead to a similar risk of enhanced local drying. Regulatory documents do not document specific pharmacokinetic interactions, such as those involving CYP enzymes or drug transporters, nor do they include timing-based separation rules for this topical formulation.

Mechanism of Action

How Dalaclin Works

The mechanism of Dalaclin is defined by its selective activity within bacterial cells, which produces two primary mechanistic consequences: the inhibition of bacterial growth and the modulation of the inflammatory stimulus.

Molecular Inhibition of Bacterial Protein Synthesis

Dalaclin’s active component, Clindamycin, acts as an inhibitor by engaging the primary biological target: the bacterial 50S ribosomal subunit. The molecule binds to the 23S ribosomal RNA ( rRNA), a component of the 50S subunit. This molecular interaction physically blocks the necessary tRNA translocation step during ribosomal translation, preventing the subsequent synthesis of structural and functional proteins. This interference with a core microbial pathway functionally leads to the arrest of bacterial growth and the resulting bacteriostatic effect.

Modulation of Microbial Virulence and the Inflammatory Response

Beyond its primary mechanistic role, Clindamycin modulates specific bacterial physiological pathways by interfering with the expression of genes that code for virulence factors and pro-inflammatory toxins. By reducing the release of these microbial products, the molecule facilitates the attenuation of the localized inflammatory response. The combined consequences of arrested microbial growth and attenuated stimulus define the drug's resulting physiological profile.

Dosage and Administration Information

The use of Dalaclin (Clindamycin Phosphate Topical) follows established parameters for application. This ensures standardized and proper use.

Administration Scope Official Guidelines
Route of Administration The medicine is strictly for topical (cutaneous) use and must not be used orally, ophthalmicly, or intravaginally.
Standard Dosing Schedule The standard regimen involves applying a thin film of the product to the entire affected skin area, typically on a twice daily schedule.
Application Procedure Prior to application, the skin must be thoroughly washed and completely dried. The product should be applied carefully to avoid contact with the eyes, mouth, lips, and other mucous membranes.
Age-Group Rules The safety and efficacy of this topical formulation have not been established for patients under 12 years of age.

Treatment Course and Duration

The medicine is used over a defined period of time. The course of treatment often requires consistent application, as the full effect may take up to 12 weeks to be observed. In instances where no clinical improvement is evident within 6 to 8 weeks, treatment may require re-evaluation. If a scheduled application is missed, the patient should continue the regimen with the next scheduled dose and should not apply a double dose to compensate. Due to its formulation, the product is noted as being flammable until dry, and users are instructed to avoid sources of heat or fire during and immediately after application.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Dalaclin (Clindamycin Phosphate Topical)

This section summarizes the official research evidence and study landscape for Dalaclin, focusing on what was studied in clinical trials and what the authorized scientific literature describes as the body of evidence. This overview is for informational purposes only and does not contain medical advice.

Evidence for Use in Acne Vulgaris

Research has primarily focused on evaluating Dalaclin's main component, topical clindamycin phosphate, for its relevance in managing acne vulgaris, particularly conditions involving inflammatory or irritative states such as papules and pustules. These areas were studied for short-term changes.

The main body of research consists of clinical trials which involve randomly assigning participants to groups (known as randomized controlled trials). In these studies, participants—mostly adolescents (aged 12 and older) and adults with mild to moderate acne—were assigned to receive either the active clindamycin formulation or an inactive vehicle (a placebo base). The studies monitored outcomes linked to inflammatory or irritative states by counting the number of lesions and using the investigator's global assessment of severity.

In the comparisons, studies reported patterns where the group using the active formulation had a higher reported average change in inflammatory lesion counts compared to the group using the inactive vehicle during the 12-week study duration. Research describes changes measured during the study period. Findings help contextualize how symptoms evolved in the observed populations under specific trial conditions.

Long-Term Studies and Durability of Response

The key research providing insight into the effects of topical clindamycin monotherapy (used alone) was conducted over defined time intervals, generally focusing on short-term symptom changes of about 10 to 12 weeks. This initial period was the focus for the primary research data.

Evidence in Special Populations

The research exploring short-term symptom changes has mainly concentrated on adolescents and adults, as these groups were generally the focus of the large clinical trials. Studies did not typically include large sample sizes of the older adult population, meaning data for certain groups remain insufficient. The results apply only to the populations studied in the trials, which generally had a confirmed diagnosis of mild to moderate acne and no major underlying health issues that would interfere with the study.

Limitations and Uncertainties Documented in the Research

A key limitation noted in the scientific literature is related to the possibility of antimicrobial resistance. Research consistently documents patterns where Cutibacterium acnes, the target bacterium, can develop resistance when topical clindamycin is used by itself over time.

Because of this reported association with resistance development, many scientific guidelines describe the use of combination therapy to mitigate this risk. The evidence for long-term, single-agent use of Dalaclin was studied for this recognized limitation. Ultimately, while research provides context on what has been observed so far in short-term, controlled settings, findings describe group patterns and do not determine whether an individual will respond similarly.

Key Studies & References

  1. Clindamycin Phosphate Topical Gel Labeling: NDA 050720
  2. Antimicrobial Resistance in Cutibacterium acnes in Acne Vulgaris: A Narrative Review
  3. Clindamycin and Benzoyl Peroxide Topical Gel Labeling: NDA 021657

Frequently Asked Questions (FAQ)

Common questions about Dalaclin (FAQ)


Q: What kinds of bacteria does Dalaclin target?

According to the official product information, the active ingredient in Dalaclin is classified as an antibiotic that targets specific bacteria. It is noted to be active against most isolates of Cutibacterium acnes (formerly Propionibacterium acnes), which is the bacteria commonly involved in the development of acne vulgaris.


Q: What happens if I miss an application of Dalaclin?

Official regulatory guidance for Dalaclin addresses how to handle a missed application. If a scheduled application is missed, the guidance indicates that patients should continue with the next regularly scheduled application. Official guidance notes that extra or double applications should not be used to compensate for a missed one.


Q: Can Dalaclin cause my skin to become more sensitive to sunlight?

Regulatory documents for some clindamycin topical formulations contain cautions related to sunlight exposure. This is based on research themes, including animal studies, that examined potential effects linked to exposure to simulated sunlight.


Q: What does the research say about Dalaclin's use alongside other antibiotic treatments?

Official regulatory labeling for Dalaclin notes potential interaction patterns with certain other antibiotics. Co-administration with antibiotics that contain Erythromycin is generally not recommended, as official documents describe a potential antagonism, which may lessen the medicine’s intended effect.


Q: Can I use Dalaclin if I am breastfeeding, according to regulatory information?

Official product information states that clindamycin has been reported to appear in breast milk. Due to the potential for serious adverse reactions in a nursing infant, regulatory documents mandate a careful decision. This decision must weigh the importance of the drug to the mother against the potential risks to the infant.


Q: Is it safe to use Dalaclin if I have eczema or psoriasis?

Official documents note that the medicine should be used with caution in atopic individuals. Atopy refers to a predisposition to allergic hypersensitivity, often including conditions like eczema. Patients with these sensitivities may have an increased likelihood of experiencing local skin reactions such as dryness, redness (erythema), and peeling.


Q: Is it true that alcohol-based skin products should be avoided while using Dalaclin?

The official labeling for Dalaclin notes constraints regarding local use with other products. Co-application with topical preparations that contain a high concentration of alcohol, such as astringents or toners, may cause an increased or cumulative irritant effect. This is because combining these products can lead to excessive drying or peeling of the skin.


Q: Why is Dalaclin not typically sold over the counter?

Official labeling designates this medicine as 'Rx only' (prescription only). This classification is consistent with the drug’s overall safety profile, which includes a major warning regarding the potential for severe, antibiotic-associated colitis. This condition can rarely occur due to the systemic absorption of the antibiotic.


Q: Is Dalaclin used for any skin conditions besides acne?

According to the official regulatory documents, the specific topical formulation of Dalaclin is indicated for the treatment of acne vulgaris. Official documents define the approved use of the medicine, which is limited to this condition.


Q: Does Dalaclin work immediately, or does it take time?

Clinical research for Dalaclin was primarily designed to assess changes over an observation period of up to 12 weeks. The full intended therapeutic effect may not be fully observed until this point. This indicates that patients in the studies required time to fully observe the intended changes.


Q: What is the difference between Dalaclin and treatments with benzoyl peroxide?

Official documents classify Dalaclin as a lincosamide antibiotic that works by inhibiting bacterial growth on the skin. Treatments containing benzoyl peroxide are distinct, and official labeling notes that co-application of these two types of treatments carries a risk of a cumulative irritant effect, which can lead to excessive drying.


Q: Is it normal to feel a stinging or burning sensation when applying Dalaclin?

Official labeling includes application site burning as a commonly reported side effect. This reaction was reported in 1% to less than 10% of patients in clinical trials. It is one of the local skin reactions documented in the adverse events profile.


Q: Does Dalaclin interact with any common vitamins or supplements?

The official regulatory documents detail known interactions with other medicines and topical agents. However, the regulatory labeling does not document any specific interactions between Dalaclin and common vitamins or nutritional supplements.


Q: Is Dalaclin the same as other clindamycin topical treatments?

Dalaclin is a brand name for a product containing the active ingredient Clindamycin Phosphate. While there are other topical treatments that contain this same active ingredient, they may be offered in different forms, such as solutions, gels, or foams, and can contain different inactive ingredients.


Q: How often do people typically need to apply Dalaclin?

Official dosage and administration sections note that the application schedule for clindamycin topical products can vary. The documented regimens described in the official labeling generally specify application once daily or twice daily, depending on the specific formulation.


Q: Can Dalaclin be used on parts of the body other than the face?

The official administration instructions describe the medication as being applied to the entire affected skin area where acne lesions are present. While commonly used on the face, the condition known as acne vulgaris can also affect other areas of the body, such as the chest, shoulders, and back.


Q: Are there different strengths or forms (like a gel vs. a solution) of Dalaclin?

The active ingredient, Clindamycin Phosphate, is typically supplied in a standardized 1% concentration. This active ingredient is available in various topical forms, including gels and solutions, as noted in the official 'How Supplied' sections.


Q: Do studies suggest Dalaclin is suitable for people with sensitive skin?

Official prescribing information notes that the medicine should be used with caution in atopic individuals. These individuals, who may have heightened skin sensitivities, are specifically noted as potentially being more susceptible to local skin reactions, such as dryness, peeling, and redness.


Q: What are the most common reasons someone might stop using Dalaclin?

The most frequently reported adverse events in clinical trials are application site reactions. These commonly include site dryness, burning sensations, itching, redness (erythema), and peeling. These localized effects are the most frequent reasons documented in studies for individuals discontinuing the use of the medicine.


Q: Does using more Dalaclin than directed lead to better or faster results?

Official administration instructions describe the application of only a thin film of the product to the affected area. Regulatory warnings state that topical clindamycin can be absorbed systemically (into the body). Using more than directed increases the potential for systemic absorption, which is associated with the risk of severe, antibiotic-associated colitis.


Q: What happens if I accidentally get Dalaclin in my eyes?

The official instructions address accidental contact with sensitive surfaces. If the medicine accidentally contacts areas such as the eyes, mucous membranes, or abraded skin, regulatory documents describe washing the affected area immediately with copious amounts of cool tap water.


Q: Is there a risk of developing resistance to Dalaclin over time?

Scientific literature and regulatory documents consistently address the possibility of resistance development. Evidence indicates that the target bacteria, Cutibacterium acnes, can develop antimicrobial resistance when the medicine is used as a single agent for an extended period.


Q: Are there regulatory guidelines on discontinuing Dalaclin use?

Official regulatory documents contain specific guidelines for discontinuation based on safety concerns. The medicine's official label states that discontinuation should occur immediately if an individual experiences significant diarrhea, due to the risk of severe, antibiotic-associated colitis.


Q: What are the primary safety considerations highlighted in official prescribing information for Dalaclin?

The primary safety consideration highlighted in the official prescribing information is the warning regarding gastrointestinal effects. This specifically addresses the risk of colitis, including severe pseudomembranous colitis, which can be associated with the systemic absorption of the antibiotic ingredient. This is the most serious risk noted in the safety summary.


How should Dalaclin be stored and disposed of?

Storage and Disposal Requirements

The official requirements for storing Dalaclin (Clindamycin Phosphate topical solution/gel) focus on temperature control and environmental protection to ensure product stability.

Requirement Category Official Storage/Disposal Rule
Temperature Requirements Store at controlled room temperature, specifically 20°C to 25°C (68°F to 77°F), and do not freeze [FDA DailyMed].
Container & Handling Keep the product in its original container, ensure it is tightly closed, and protect it from excessive heat [FDA DailyMed].
Child Safety The medicine must be kept out of the sight and reach of children [FDA DailyMed; MHRA SmPC].
Disposal Mandate Do not dispose of via wastewater or household trash; instead, return any unused or expired product to a pharmacist for proper environmental waste handling [MHRA SmPC].

These directives strictly define the necessary storage environment and outline the mandatory procedure for discarding the medicine to prevent environmental contamination.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Dalaclin found in:

A-Z Index: