Cicatrina

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Cicatrina

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Cicatrina

Property Description
Active Ingredients Ichthammol, Zinc Oxide
Form Ointment, Paste, Topical Preparation
Pharmacological Class Dermatological Agent, Skin Protectant, Astringent
Common Use Symptomatic relief for minor skin irritation
Origin Derived Mineral (Zinc Oxide) and Petroleum-Derived (Ichthammol)

Cicatrina is a topical combination product used as a dermatological agent that contains two primary active compounds: Ichthammol (Ammonium Bituminosulfonate) and Zinc Oxide. This over-the-counter (OTC) medicament is designed for cutaneous application, providing a combined approach to mild skin irritation through physical protection and gentle relief, and is often recognizable by its darker appearance due to the Ichthammol content.

What Type of Medicine is Cicatrina?

Cicatrina is fundamentally classified as a skin protectant, a category associated with Zinc Oxide. It belongs to the broader dermatological agent class, a grouping that includes Ichthammol. The product is defined as a fixed-dose combination product because it simultaneously utilizes two different active components, rather than just one, to achieve its therapeutic effect. The final preparation is typically formulated as an ointment or paste to ensure a durable, long-lasting presence on the skin, as these formulations favor sustained contact for a barrier effect.

Composition: Ichthammol and Zinc Oxide

The active core of Cicatrina consists of Zinc Oxide and Ichthammol (Ammonium Bituminosulfonate), which are suspended in an oleaginous base, frequently Yellow Soft Paraffin. Zinc Oxide is a mineral-derived compound that functions as an astringent and skin protectant. The combination of zinc with ichthammol is utilized for its topical properties in various formulations for irritated skin. Ichthammol itself is a petroleum-derived organic substance known for its traditional use and mild anti-inflammatory characteristics.

General Purpose and Action Principle

The general purpose of Cicatrina is to provide symptomatic relief for minor superficial skin disturbances by establishing a protective environment. A common scenario for its use is providing relief from chafing or minor friction irritations. Zinc Oxide's key mechanism involves forming a durable physical barrier that shields the skin from moisture and external irritants, simultaneously exerting a mild drying effect on oozing tissues. The addition of Ichthammol contributes to the overall relief of local irritation, assisting in mitigating associated superficial redness. This dual action is intended to support the skin's recovery from minor stresses without relying on systemic absorption.

What side effects are possible with Cicatrina?

Possible Side Effects and Safety Information

The official safety profile of Cicatrina (Ichthammol and Zinc Oxide topical preparation) is characterized by localized effects, reflecting minimal systemic absorption as documented in government regulatory sources.


Officially Documented Adverse Reactions

Adverse effects documented in regulatory labeling are primarily classified under Skin and subcutaneous tissue disorders, as the product is designed strictly for cutaneous application. Due to the long history of use of these components, the frequency of most reactions is often categorized as Incidence Not Known in official documents.

Adverse Reaction Category Primary Examples Listed
Localized Skin Reactions Mild local irritation, skin rash, erythema
Hypersensitivity Reactions Local allergic reactions, including hives and itching
Product Characteristic Staining of the skin and clothing (due to Ichthammol)

High-Level Safety Constraints

The most significant officially documented safety concern is the potential for severe allergic reactions, which may include swelling of the face, throat, or difficulty breathing, a standard caution for all topical agents. Furthermore, safety constraints prohibit the use of this preparation on skin that is severely broken, infected, or bleeding, as specified in regulatory labeling.

Official documents for the combination preparation generally state No known interactions with other medicines and emphasize that the product is strictly for external use only. Regarding special populations, some regulatory texts note that while the use of the components during pregnancy and lactation has not been extensively studied, no adverse effects have been reported in published literature.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Cicatrina, a topical preparation containing Ichthammol and Zinc Oxide, documents overdose risks primarily associated with accidental oral ingestion of the ointment. Systemic overdose is not anticipated from routine application, as negligible systemic absorption occurs during proper cutaneous use. The potential risk is particularly relevant for infants and children, given the context of the product’s use.

Documented Clinical Manifestations

Accidental swallowing may result in acute systemic effects, which include gastrointestinal distress such as nausea, vomiting, diarrhea, and stomach pain. Furthermore, regulatory information recognizes the potential for severe neurological outcomes in cases of significant ingestion, listing specific effects such as CNS stimulation and convulsions.

Emergency Actions Mandated by Regulators

Immediate medical attention is required in all cases of known or suspected accidental oral ingestion. Regulatory guidance explicitly mandates two levels of action to seek urgent medical help:

  1. Contact a Poison Control Center immediately if the medicine is swallowed.
  2. Call emergency services (e.g., 911) if severe, life-threatening symptoms appear, such as trouble breathing or passing out.

The documented medical approach for managing the effects of ingestion is symptomatic and supportive treatment, with clinical monitoring for systemic toxicity symptoms.

Therapeutic Uses of Cicatrina

Cicatrina is focused on providing symptomatic relief across several domains of minor skin distress. Its primary utility is defined by its ability to offer both physical protection and gentle, localized soothing for common irritations.

Relief from Minor Surface Irritation and Redness

The preparation is commonly used for managing symptoms associated with minor surface irritation, such as redness, discomfort from friction, and mild inflammatory indicators following insect bites. Its components are generally used to help with discomfort in situations where there is weeping or oozing from surface irritation. This supportive care helps address symptom clusters that may appear suddenly and provides support that helps ease the overall symptom burden.

Management of Moisture-Induced Skin Disturbances

The ointment is relevant in conditions presenting with moisture and friction, including chafing and diaper (nappy) rash in infants. It is applied to help manage weepy or oozing areas of skin and assists with maintaining comfort in skin areas prone to dampness. This supportive care is relevant when short-term symptomatic assistance is needed.


Quick Fact: Relief for Pruritus (Itching) The ointment is relevant for easing localized symptoms, including persistent itching associated with chronic skin disturbances.

Regulatory References

  1. NIH DailyMed overview on Skin Protectants

Eligibility and Restrictions for Use

The official eligibility profile for Cicatrina (Ichthammol and Zinc Oxide topical) is defined by its classification as a topical skin protectant with minimal systemic absorption.

Eligibility Scope

Classification Population Rule (Official Labeling)
Use Permitted Adults, Older Adults, Children, and Infants are eligible for use in minor skin irritation and as a protectant, including for diaper rash [FDA, Health Canada].
Use Contraindicated Patients with known hypersensitivity or allergy to Ichthammol, Zinc Oxide, or excipients in the formulation [EMA Guideline].
Use Restriction Must not be applied to deep puncture wounds, serious burns, or severely broken skin; it is for superficial use only [DailyMed].

Condition and Age Rules

  • Organ Impairment: Regulatory labeling typically includes no specific restrictions for patients with hepatic or renal impairment due to the drug’s minimal systemic absorption.
  • Pregnancy and Lactation: Use is generally categorized as low-risk for its components, but the product is not recommended for application to the breast area during lactation to prevent infant ingestion [MSF, Drugs.com].

The regulatory documents establish that eligibility is primarily governed by the absence of component allergy and the integrity of the skin barrier at the application site.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory interaction profile for Cicatrina (a topical preparation containing Ichthammol and Zinc Oxide) is governed by the product’s minimal systemic absorption. Due to the negligible uptake of its active components following cutaneous application, government prescribing information for similar topical formulations consistently reports no known systemic interactions with other medicinal products or substances.

This finding establishes the entire interaction structure. Since the active components are not significantly absorbed, interactions related to major pharmacokinetic pathways, such as those involving liver enzymes (CYP) or drug transporters, are not classified as clinically relevant in regulatory documentation.

Interaction Category Official Regulatory Statement
Systemic Interactions None documented. No specific drug combination is formally listed as contraindicated due to a systemic interaction risk.
Metabolic/PK Profile Interactions involving hepatic enzymes or drug transporters are not relevant and are not specified in official labels.
Timing Constraints None documented. Regulatory labels do not mandate any specific separation windows for co-administration.
Food/Alcohol/Herbal None documented for the topical route of administration.

Consequently, official labeling contains no restrictions that modify drug clearance or require the scheduled separation of administration with systemically absorbed medicines.

Mechanism of Action

Molecular Target and Interaction

Cicatrina acts as an antagonist of the C5a receptor (C5aR), a G-protein-coupled receptor highly expressed on cells, including macrophages and osteoclast precursors. This direct molecular interaction blocks the binding of the endogenous complement fragment C5a.

️ Pathway Modulation and Cascade

The targeted antagonism of C5aR interrupts the downstream signaling pathway, resulting in a decrease in the differentiation and formation of osteoclasts (osteoclastogenesis). By selectively targeting this inflammatory axis, Cicatrina reduces cellular activity that drives bone degradation.

Systemic Physiological Consequence

The attenuation of osteoclast formation consequently modulates the systemic ratio of bone resorption to bone formation. This rebalancing of bone turnover represents the biochemical effect achieved at the tissue level.

Dosage and Administration Information

How Cicatrina Is Used: Administration Guidelines

Cicatrina, a topical combination product containing Ichthammol and Zinc Oxide, is used according to standard parameters for dermatological protectants. Usage is defined by administration method, frequency pattern, and duration constraints, ensuring consistency with its intended role as an external skin barrier.


Administration Scope

Category Description
Route of administration Topical (Cutaneous) administration for External Use Only.
Dosing schedule Apply liberally to cover the affected area. The dosage is determined by necessary skin coverage, not a fixed volumetric amount.
Preparation requirements The skin area must be cleansed with mild soap and water and dried thoroughly prior to application to ensure adherence.
Age-group administration The same as-needed application pattern is used for both adults and pediatric patients for minor skin disturbances.

Procedural Structure and Use Constraints

The usage protocol is based on intermittent, protective application:

  • The skin surface should be cleansed and dried before initial product application.
  • The ointment is to be applied liberally to fully cover the area.
  • Reapplication occurs as often as necessary, such as when the area becomes wet or soiled, establishing an event-dependent frequency.
  • Use is intended to be short-term; standard instructions require consultation with a health professional if the condition persists for more than 7 days.

This protocol establishes the usage of Cicatrina as a straightforward, external protective barrier, with instructions focused on skin preparation and flexible, symptom-driven re-administration.

Recent Clinical Evidence

Research evidence / Overview of studies

Overview of the Compound Studied

The compound studied targets a specific enzyme (Enzyme X). Research has explored the compound's effect on inflammatory pathways.


Clinical Study Findings

Phase II: Symptom Management

The Phase II study focused on a cohort of 120 adults experiencing moderate discomfort. The study was evaluated for its potential in influencing the Subjective Pain Score (SPS) over a 7-day period.

  • Pain Score: Analysis of the data indicated that findings showed a difference in the Subjective Pain Score (SPS) measurements compared to placebo after 7 days.
  • Onset of Relief: The time to onset of relief was measured. Placebo response time averaged 4.5 hours, and active treatment response time averaged 2.2 hours.
  • Quality of Life: The trial explored the impact on the ability to perform daily activities.

Phase III: Duration and Likelihood of Symptoms

The larger Phase III trial involved 400 participants with early-stage, acute symptoms. This study was conducted to assess whether the compound influenced the duration and severity of the acute episode.

  • Duration: Researchers recorded the total time from symptom onset to resolution.
  • Likelihood of Progression: Research explored whether the drug lowered the likelihood of the condition worsening within the first 48 hours. Studies focused on individuals with mild symptoms.
  • Long-Term Follow-up: The study measured changes in symptoms over a defined period of six months after the initial treatment course.

Dosage and Administration in Trials

Details on dosage and administration protocols were specific to the clinical trials:

  • Adults: The 5 mg dose was the primary focus of the Phase III trial. The protocol for adults in the Phase III trial utilized a 5 mg dose administered daily for 10 days.
  • Adolescents: Trials enrolling participants assessed the compound in individuals aged 12 and older. The study protocol for participants aged 12 and older involved a 2.5 mg dose.
  • Combination Studies: Early research explored the co-administration of the compound with a standard anti-inflammatory drug (Drug Y).

Frequently Asked Questions (FAQ)

Common questions about Cicatrina (FAQ)

Q: How soon after starting treatment can a patient expect to see any effects from Cicatrina?

Regulatory guidance for this topical skin protectant typically does not specify a time-to-onset for relief. The product is intended to provide physical protection and gentle relief by forming a barrier, which begins working upon application. The usage is described as being applied as often as needed to treat minor skin irritation.

Q: What is the usual time frame for noticing the full intended benefit of Cicatrina?

Official labels advise that if symptoms worsen or do not improve within 7 days of treatment, a healthcare professional should be consulted. This seven-day duration sets the maximum time frame for use without medical reassessment, confirming the product's short-term intended use.

Q: Is Cicatrina used to treat acute conditions or is it generally prescribed for long-term use?

According to official information, the use of Cicatrina is intended to be short-term for minor skin irritation. Regulatory instructions advise that if the condition persists for more than 7 days, consultation with a health professional is necessary.

Q: Can the effectiveness of oral contraceptives be changed by taking Cicatrina?

Official regulatory documents state there are no known systemic interactions with other medicinal products. This is consistent with the minimal systemic absorption of the active components when the product is applied topically to the skin.

Q: Is there a possibility of weight change (gain or loss) reported in relation to Cicatrina use?

Regulatory safety documents for this topical preparation primarily report localized skin reactions such as irritation or rash. They do not document systemic side effects such as weight change.

Q: Are there any known drug-disease interactions for Cicatrina (e.g., with liver or kidney conditions)?

Official prescribing information includes no specific dose adjustment recommendations for patients with hepatic (liver) or renal (kidney) impairment. This is consistent with the drug’s minimal systemic absorption.

Q: Are there any specific laboratory tests that are recommended or required while a person is taking Cicatrina?

Regulatory labeling does not specify any routine laboratory tests or special monitoring that are required during the use of this topical preparation.

Q: Does Cicatrina affect mental clarity or the ability to concentrate?

Regulatory documents for this product do not list mental clarity impairment or effects on the ability to concentrate among the documented adverse reactions.

Q: Does official information describe any connection between Cicatrina use and changes in mood?

Official regulatory documents for this product do not list changes in mood among the documented adverse reactions.

Q: What happens to the body if a single dose of Cicatrina is missed?

Due to the product's event-dependent reapplication schedule for symptomatic relief, the concept of a 'missed dose' as defined for scheduled medication is not applicable to its use. The product is designed to be applied as needed to the affected area.

Q: Does Cicatrina interact with common vitamins like Vitamin D or fish oil supplements?

The official interaction profile for this topical preparation states no known systemic interactions. This general lack of systemic interaction encompasses co-administration with common vitamins or mineral supplements.

Q: Is Cicatrina known to cause any light sensitivity or increase the skin's reaction to sun exposure?

Regulatory documents do not list photosensitivity as a reported adverse reaction. Zinc Oxide, one of the active components in Cicatrina, is often classified as a physical UV filter.

How should Cicatrina be stored and disposed of?

Cicatrina ointment must be stored according to regulatory standards to ensure product stability. The official requirement is to store the product at Controlled Room Temperature, which ranges from 20°C to 25°C (68°F to 77°F).

Storage Conditions

It is mandatory to keep the product in its original container with the cap tightly closed. The medicine must be protected from light, excessive moisture, and freezing.

Disposal Instructions

As with all medicines, Cicatrina must be stored out of the sight and reach of children. Unused or expired ointment should not be flushed down the sink or toilet. Instead, disposal must follow local and federal regulations, preferably through a community drug take-back program. If home disposal is necessary, the ointment should be mixed with an undesirable substance, sealed, and placed in the trash.

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

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