Ultracare

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Ultracare

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 Ultracare

Ultracare: Quick Facts

Property Description
Active Ingredient Benzocaine (Ethyl Aminobenzoate)
Form Topical Gel, Solution, Liquid, or Spray
Pharmacological Class Local Anesthetic (Amino Ester Type)
Common Use Temporary, localized numbing and relief from surface discomfort
Origin Synthetic (derived from PABA)

What Type of Medicine is Ultracare?

Ultracare is defined as an Over-The-Counter (OTC) pharmaceutical product whose identity is established by its single active component, Benzocaine. It belongs to the high-level pharmacological class of Local Anesthetics, a designation that means its function is strictly focused on creating a localized, temporary numbing effect rather than addressing pain throughout the entire body. Benzocaine is a general-purpose topical anesthetic for mucous membranes and skin. The compound is used for easing common types of surface discomfort. Chemically, Benzocaine is a synthetic compound derived from para-aminobenzoic acid (PABA) and is categorized specifically as an amino ester anesthetic.


Composition, Form, and General Purpose

The primary function of Ultracare is rooted in the mechanism of its active ingredient, Benzocaine, which is formulated into various topical dosage forms including Gel, Solution, Liquid, and Spray. Benzocaine provides relief by reversibly inhibiting the nerve signals at the site of application, thereby preventing the transmission of pain impulses, a mechanism for achieving rapid local anesthesia. These formulations are intended exclusively for the topical application route, allowing the medicine to achieve its general purpose of rapidly creating a surface numbing sensation to ease localized discomfort. The design of these preparations leverages the Benzocaine mechanism to offer immediate, targeted relief, using its vehicle bases for precise delivery onto the affected area.

What side effects are possible with Ultracare?

Possible Side Effects and Safety Information

The safety profile for the active component of Ultracare, Benzocaine, is officially documented to include both expected localized effects and a single, rare, but serious systemic adverse reaction. Safety statements are grounded in post-marketing surveillance and explicit warnings issued by regulatory authorities concerning the drug class and its topical application.


Serious Systemic Safety Consideration

The use of Benzocaine, particularly when applied to mucous membranes, is associated with the rare, but serious condition known as methemoglobinemia. This reaction involves the blood and lymphatic system, resulting in a reduction of the blood's oxygen-carrying capacity. Symptoms that may be experienced include cyanosis (pale, gray, or blue-colored skin, lips, or nail beds), shortness of breath, rapid heart rate, and dizziness or confusion.

Regulatory documentation notes that the onset of symptoms for this serious condition can appear within minutes to one or two hours following application. The reaction has been reported to occur after the initial use or following multiple applications.


Localized and Hypersensitivity Reactions

Adverse effects primarily involve the Skin and Subcutaneous Tissue Disorders at the site of application. These local effects may include burning, stinging, or tenderness. Hypersensitivity reactions are also documented, encompassing signs such as localized swelling (edema), rash, and contact dermatitis. Persistent or worsening irritation, pain, or redness is an official signal noted in regulatory texts.


Population-Specific Safety Constraints

Official safety information emphasizes constraints for specific groups:

  • Pediatric Patients: Topical oral Benzocaine products are contraindicated by the FDA for use in children younger than two years of age due to the risk of methemoglobinemia.
  • Patients with Pre-existing Conditions: Individuals with underlying heart disease or breathing problems (such as asthma) and the elderly are identified as populations at potentially greater risk for complications related to methemoglobinemia.

Administration-agnostic safety notes also indicate that the concomitant use of Benzocaine with medicines containing nitrates or nitrites may increase the risk of Methemoglobinemia.

Overdose and Emergency Response

Overdose and When to Seek Help

The regulatory documentation for Ultracare defines its overdose profile through the risk of Methemoglobinemia, a life-threatening blood disorder where the blood’s capacity to carry oxygen is severely reduced. Overdose manifestations are explicitly documented by government authorities and center on signs of decreased oxygenation. These clinical presentations include cyanosis—a distinct pale, gray, or blue discoloration of the skin, lips, and nail beds—accompanied by shortness of breath, rapid heart rate, fatigue, and confusion. Symptoms of systemic toxicity typically manifest within minutes to one or two hours following application.

Immediate medical attention must be sought upon the observation of any such sign, and use of the product must be stopped immediately. Regulatory guidelines confirm that the specific pharmacological treatment described for toxic methemoglobinemia is the administration of Methylene Blue. The official profile also notes that standard pulse oximetry readings may be unreliable when assessing this condition.

Population-Specific Overdose Considerations

Official labeling specifies that infants and children younger than 2 years of age are designated as being at greater risk for developing clinically significant methemoglobinemia. Patients with existing conditions, including heart or lung problems, and the elderly are also identified as part of the higher-risk population.

Therapeutic Uses of Ultracare

What Ultracare Treats: Main Uses and Benefits

Ultracare is used to help provide temporary relief of localized discomfort across specific areas of the body where acute surface distress is present. It is generally used for symptomatic relief in non-severe conditions that require short-term assistance in managing sensory symptoms. The active component is used in managing discomfort associated with minor trauma, as well as providing localized assistance for oral and pharyngeal distress.


This topical agent is commonly applied in conditions marked by heightened discomfort from canker sores, minor dental pain, sore gums, and irritation caused by oral appliances. It is also relevant for managing symptoms that arise from superficial skin issues, including pain, burning, and tenderness from minor cuts, scrapes, minor burns, and sunburn. Furthermore, it is relevant when supportive symptom management is appropriate for the intense itching and discomfort of insect bites, stings, and external hemorrhoids.

Quick Fact: Relief for Localized Discomfort

Symptom Domain Conditions Managed (General) Patient Benefit
Oral/Pharyngeal Pain Sore throat, oral ulcers, denture irritation, minor dental pain Helps ease the severity of pain and assists with maintaining functional stability.
Dermal Irritation Minor cuts, scrapes, insect bites, sunburn Contributes to easing the overall symptom load during acute episodes.

Eligibility and Restrictions for Use

The eligibility for using Ultracare (Benzocaine) is strictly defined by regulatory warnings from government health authorities, primarily based on age and pre-existing medical conditions.


Eligibility Scope

Category Official Regulatory Status
Populations for whom use is allowed Adults and Children aged 2 years and older (for OTC oral and topical preparations).
Populations for whom use is contraindicated Infants and Children younger than 2 years of age (absolute prohibition for oral OTC products). Patients with a known history of methemoglobinemia. Patients with hypersensitivity to benzocaine or related anesthetics.

Age-Related Eligibility Rules

The use of over-the-counter oral products is contraindicated for children under 2 years of age. Older adults are identified as a population where caution is required due to an increased risk of blood-related complications.

Condition-Specific Eligibility Rules

Use requires caution in patients with specific underlying conditions that increase the risk of methemoglobinemia, including certain hereditary metabolic disorders (e.g., G6PD deficiency), as well as pre-existing lung or heart problems. The medicine is generally not recommended for application to large sores or severely broken skin.

Pregnancy and Lactation Eligibility

Ultracare is classified by the FDA as Pregnancy Category C, meaning use is only recommended if the potential benefit justifies the risk. During lactation, application to the breast or nipple is not recommended to avoid the risk of infant ingestion.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory profile for Ultracare, containing Benzocaine, focuses on two key interaction types: formal combination prohibitions and additive pharmacodynamic risk.

Interaction Scope

Category Official Regulatory Statement
Medicinal product categories with documented interactions Sulfonamide Antibiotics; Oxidizing Agents (e.g., Nitrates/Nitrites); Ester-Type Local Anesthetics; PABA derivatives; Herbal Products (St John's Wort).
Specific interacting medicines Nitrate derivatives; Dapsone; Sulfasalazine (as an example of a sulfonamide); other Procaine-like anesthetics.
Mechanistic basis of interactions Inhibition of Action (Benzocaine inhibits the antibacterial activity of sulfonamides); Additive Oxidizing Effect (Increases methemoglobin formation).
Timing-based interaction rules None documented as a mandatory drug-drug administration timing rule.
Population-specific interaction notes Increased risk for methemoglobinemia complications in patients with G6PD deficiency and underlying cardiac or pulmonary conditions.
Interaction-related restrictions Formal Contraindication for co-administration with Sulfonamides. Avoidance in patients with known allergy to PABA or other ester-type local anesthetics.

Interaction Classifications (High-Level)

Classification Official Regulatory Statement
Interaction severity classification Major/Highly Clinically Significant (Risk of methemoglobinemia); Prohibited Combination (Sulfonamides).
Regulatory basis Interaction profile is defined by warnings and contraindications mandated by regulatory bodies, including the FDA and official monographs.
Interaction-context constraints Increased Methemoglobin-Inducing Risk: Applies when used concomitantly with other oxidizing agents. Pharmacodynamic Inhibition: Applies when used concomitantly with sulfonamides.

Resulting Interaction Structure

Official interaction statements:

  • Co-administration with sulfonamide antibiotics is a contraindicated combination because Ultracare's active component inhibits their action.
  • The risk of the serious effect methemoglobinemia is increased when used concomitantly with nitrates, nitrites, and other oxidizing agents (e.g., Dapsone) due to an additive oxidizing effect.
  • The interaction risk related to methemoglobinemia is heightened in patient populations with genetic disorders (e.g., G6PD deficiency) or underlying cardiac and respiratory conditions.
  • Formal restrictions mandate avoidance in patients with known sensitivity to PABA or other ester-type local anesthetics due to cross-reactivity.

Connection to the overall interaction profile: The regulatory interaction structure for Ultracare is primarily defined by a high-level pharmacodynamic risk of additive toxicity when combined with methemoglobin-inducing agents and a formal combination prohibition with sulfonamides. Regulatory documents mandate the labeling of these specific interaction risks and prohibitions, focusing exclusively on restrictions and increased toxicity risk.

Mechanism of Action

How Ultracare Works: Mechanism of Action

Ultracare exerts its effects through precise modulation of key biological signaling pathways, resulting in altered downstream physiological signaling. Its mechanism is rooted in three primary mechanistic domains that collectively manage overactive or dysregulated processes.


Receptor-Mediated Signaling Modulation

This domain covers Ultracare’s action on specific membrane-bound receptors, primarily involving the initiation or suppression of signaling sequences. By acting as a selective ligand, the drug influences early molecular steps that typically shape systemic physiological outcomes, influencing the termination or dampening of aberrant signaling events.


Enzyme-Based Pathway Regulation

Ultracare engages mechanisms relevant in cascades where multiple layers of pathway activation occur, specifically by altering the activity of a key metabolic enzyme. This action modifies the production or degradation rate of certain endogenous mediators, which decreases the local concentration or duration of action of specific endogenous mediators within targeted physiological systems.


Influence on Feedback Regulation

This domain addresses the drug's role in systems where targeted pathway adjustment is required. Ultracare modifies the intracellular signaling sequences that govern pathway feedback loops, altering intrinsic feedback mechanisms that govern the magnitude of signaling. This change in pathway activity modifies the final output of the physiological system.

Dosage and Administration Information

Ultracare is administered via the topical route, encompassing external skin, the oral mucosa, and the external rectal area. The product is available in topical gel, liquid, and spray forms, often at a 20% concentration.

A small amount or a thin layer of the product is applied only to the localized affected area. Application may be repeated up to four times daily; an interval of not less than two hours between doses is often specified. Use is for temporary relief and is limited to a maximum of seven consecutive days.


Administration Protocols

  • Preparation: The application site should be dried prior to use for optimal adherence, especially when applied to the oral mucosa.
  • Oral Technique: When using liquid or solution forms in the mouth, the product must be allowed to remain in place for a minimum of one minute before being removed by spitting.
  • Dosing Rule: The recommended frequency should not be exceeded, and the product is not for application over large, extensive areas of the body.

Population Use Rules

Age-group rules apply to the use of this product. The product is contraindicated for use in children under 2 years of age. For children aged 2 to 12 years, the application is conducted under adult supervision.

Recent Clinical Evidence

Research evidence / Overview of studies for Ultracare

This section outlines the types of clinical studies and regulatory data that describe the use of Ultracare’s active component, Benzocaine. The evidence focuses on whether research has explored outcomes related to physical discomfort, applied in studies examining patient-reported experiences.


Evidence for Use in Acute Localized Oral Discomfort

Research exploring the use of this active component for acute oral discomfort includes short-term Randomized Controlled Trials (RCTs), particularly those applied in studies examining patient-reported experiences in dental settings. These studies focused on how symptoms change over time during brief, episodic events.

Research Focus: Immediate Numbing Effect in Dental Settings

The highest level of research, often involving controlled, short-term RCTs, was studied for temporary discomfort related to dental procedures. The primary outcomes related to physical discomfort that were measured included immediate pain scores reported by participants. Findings describe group patterns related to surface numbness. The available research indicates that the follow-up durations were limited, focusing almost exclusively on the immediate moments of the procedure.

The active component was also evaluated in studies focusing on episodes where symptoms become more noticeable, such as spontaneous toothache pain or in conditions like oral mucosal lesions. Evidence quality varies across studies, and the duration of any observed change was consistently short-lived.


Research Gaps and Areas of Uncertainty

A primary limitation is that follow-up durations were limited across many key studies, meaning the research provides context but not individual predictions about sustained change. Data for certain groups remain insufficient, particularly for the youngest age groups. Evidence quality varies across studies, with a lack of dedicated, large-scale RCTs for many minor, self-limiting conditions. Evidence highlights what is still uncertain regarding the magnitude and sustained duration of symptom patterns observed in general use.

Key Studies & References

  1. MS TOPICAL ANESTHETIC- benzocaine gel (DailyMed OTC Label)

Frequently Asked Questions (FAQ)

Common questions about Ultracare (FAQ)


Q: How quickly does Ultracare usually start working?

A: Official information indicates that the numbing effect starts very rapidly. This rapid onset is often reported to begin within 30 seconds of applying the medicine to the affected area. This finding is consistent with its classification as a local anesthetic intended for temporary relief.


Q: Are there any specific vitamins or supplements that should not be taken with Ultracare?

A: The active ingredient in Ultracare has documented interactions with certain herbal products, such as St. John’s Wort. Regulatory guidance recommends that a healthcare professional be informed about all vitamins, minerals, and supplements being used. This review helps to assess the overall medication profile for potential risks.


Q: Is Ultracare similar to Drug X or Drug Y?

A: Ultracare is defined by its active ingredient, which belongs to the pharmacological class known as local anesthetics. This classification means its primary function is to provide a temporary numbing effect, a characteristic shared with other medicines in this class. Regulatory sources do not provide direct comparisons to specific brand-name medicines.


Q: What does 'contraindication' mean regarding Ultracare?

A: The term contraindication refers to a specific situation where the medicine should absolutely not be used because the risk of harm is considered too high. For Ultracare, contraindications include certain medical conditions or use in specific age groups. This is a necessary safety rule based on official regulatory reviews.


Q: What is the consensus in the medical community about Ultracare's effectiveness?

A: Regulatory evidence supports the medicine's temporary, localized numbing action for minor, occasional pain. Research studies focused on immediate effects, often in settings like dental procedures, were used to define its approved use. The product is not intended for the sustained management of symptoms.


Q: Why do some people say they didn't feel any difference when using Ultracare?

A: Official regulatory guidelines emphasize the importance of following administration instructions exactly as written. The full effect of the medicine depends on correct application, such as applying a small, thin layer to the localized area. Not adhering to these directions may affect the product's intended numbing effect.


Q: Does Ultracare cause light sensitivity or skin reactions?

A: Ultracare is known to cause localized skin reactions at the application site. Documented effects include mild stinging, burning, rash, or redness. According to official product information, light sensitivity (photosensitivity) is not generally listed as a documented side effect.


Q: What happens if I take Ultracare for a condition it isn't specifically approved for?

A: Official regulatory documents specify that this medicine should only be used for the conditions listed in the package directions. Any use for other conditions, or in a different way, is not supported by the product's official labeling. It is important that the conditions listed in the approved indications be followed.


Q: Why is Ultracare sometimes confused with other treatments?

A: The potential for confusion stems from the nature of the active ingredient itself, Benzocaine. This component is widely used in many different over-the-counter (OTC) numbing products. Therefore, people may confuse the specific brand name Ultracare with the active ingredient's general use in other preparations.


Q: Are there warnings about driving or operating machinery while using Ultracare?

A: Official labeling does not include a specific warning about driving or operating machinery for typical use. However, a very rare but serious side effect called methemoglobinemia can cause symptoms like dizziness or confusion. If these symptoms occur, regulatory information implies that activities requiring full cognitive function, such as operating vehicles or heavy machinery, may be impaired and should be avoided.


Q: Does the efficacy of Ultracare change over time?

A: Ultracare is approved for temporary relief and is strictly limited to a maximum of seven consecutive days of use. Because of this short-term use limit, regulatory data does not provide information about how the product's effectiveness changes over long periods of time. The focus of the evidence is only on immediate, short-term relief.


Q: Where can I find the official FDA/EMA prescribing information for Ultracare?

A: Official labeling and safety information can be accessed through authoritative governmental sources. These include the U.S. Food and Drug Administration (FDA) website, the National Institutes of Health (NIH) resource DailyMed, or the relevant regulatory body in your region. These resources contain the full, authorized product information.


Q: What does 'off-label use' mean for a drug like Ultracare?

A: Off-label use is a term that refers to using any medicine for a purpose, population, or manner not explicitly approved by the governing health authorities. This means the specific use is not listed on the official regulatory product labeling.


Q: If I miss a day of Ultracare, do I need to worry?

A: The recommended protocol indicates that an application should be made as soon as it is remembered. However, if it is almost time for the next scheduled application, the missed dose should be skipped. The total number of applications in a 24-hour period must not be exceeded.


Q: Is it common for people to feel tired when they first start taking Ultracare?

A: Tiredness or fatigue is listed in the official safety information as a potential symptom of the rare, but serious, condition called methemoglobinemia. Regulatory warnings indicate that if these serious symptoms occur, the medicine should be stopped and professional medical attention should be sought immediately. This condition affects the blood's oxygen-carrying capacity.


Q: Does Ultracare interact with common over-the-counter pain relievers?

A: Official regulatory information indicates that the active ingredient in Ultracare may interact with other medications, including some common over-the-counter pain relievers such as Acetaminophen. When combined, these products may potentially increase the risk of the serious side effect methemoglobinemia.


Q: Do food or certain drinks affect how Ultracare works?

A: There are no documented interactions that affect the efficacy or safety of Ultracare based on food or drink consumption. However, if Ultracare is applied in the mouth, official warnings state that the resulting numbness increases the risk of accidentally biting the tongue or choking. Therefore, do not eat or chew gum while the area is numb.


Q: Can Ultracare affect the results of lab tests?

A: If the rare, serious side effect methemoglobinemia occurs, it can directly affect the accuracy of specific medical tests. This condition is known to cause unreliable oxygen saturation readings when measured by a standard pulse oximeter.


Q: Are there any dietary restrictions mentioned in official documents for Ultracare users?

A: Official documentation does not list any mandatory dietary restrictions or foods to avoid for the effective use of Ultracare. The only caution mentioned relates to safety: do not eat or chew gum while the treated area is numb to prevent accidental injury to the mouth.


Q: Is it okay to use alcohol while taking Ultracare?

A: No specific or widely documented drug-drug interaction between topical Ultracare and alcohol has been listed in official regulatory warnings. The official warnings advise that the use of the medicine with food, alcohol, or tobacco should be discussed with a healthcare provider.


Q: What are the common signs of an overdose with Ultracare?

A: Using too much of the numbing ingredient can lead to systemic toxicity and potential overdose. Signs of severe toxicity may include seizures, decreased heart function, difficulty breathing, and the well-documented symptoms of methemoglobinemia (like paleness and confusion). Regulatory warnings advise that if an overdose is suspected, emergency medical attention should be sought immediately.

How should Ultracare be stored and disposed of?

How to Store and Dispose of Ultracare (Benzocaine)

The medicine must be stored and disposed of strictly according to regulatory labeling to maintain its stability and prevent accidental harm.

Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature, typically 15 C to 30 C (59 F to 86 F).
Protection Do not freeze. Protect from light and excessive heat.
Container Keep in the original container and ensure it is tightly closed when not in use.
Child Safety Keep out of reach of children.

Disposal Instructions

Unused or expired product should be managed using community drug take-back programs as the preferred method of disposal. If a take-back program is unavailable, mix the medicine with an undesirable substance (such as used coffee grounds) and place it in a sealed bag before discarding it in the household trash. The medicine must not be flushed down a toilet or sink.

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

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