Restoral

Description

Restoral is a topical analgesic ointment available in two net weights: 54.1 grams (1.91 ounces) and 13.5 grams (0.47 ounces). This formulation is designed for local application to provide relief from pain.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application does not exceed this frequency to avoid potential adverse effects.

This medication is not recommended for use in children under 12 years of age. Healthcare professionals should exercise caution and consider alternative treatments for this population.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to marshmallow root or chickweed.

Application on wounds or damaged skin is not recommended due to the potential for irritation or adverse reactions.

Additionally, contact with eyes and mucous membranes should be avoided; in the event of contact, rinse thoroughly with vegetable oil.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame to prevent any risk of ignition.

The presence of marshmallow herb in this formulation may enhance the topical anti-inflammatory effects of steroids. Healthcare professionals should be aware of this potential interaction when advising patients on concurrent use of topical steroids.

Contact with eyes and mucous membranes should be avoided. In the event of accidental contact, it is recommended to rinse the affected area with vegetable oil to mitigate irritation.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

This product should not be applied to wounds or damaged skin, as this may lead to adverse effects. Additionally, individuals with known allergies to marshmallow root or chickweed should refrain from using this product to avoid allergic reactions.

In cases of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Centre is advised.

For pregnant or breastfeeding individuals, it is essential to consult a healthcare professional prior to use to ensure safety for both the mother and child.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is for external use only and is flammable; therefore, it should be kept away from fire or flame. The presence of marshmallow herb may lead to increased topical anti-inflammatory effects of steroids, which should be considered when using this product.

During use, patients should avoid contact with the eyes and mucous membranes. In the event of contact, it is recommended to rinse the affected area with vegetable oil. Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

This product should not be applied to wounds or damaged skin, and it is contraindicated in individuals who are allergic to marshmallow root or chickweed. Additionally, pregnant or breastfeeding patients should seek advice from a healthcare professional before using this product.

It is crucial to keep this product out of reach of children. If the product is swallowed, patients should seek medical assistance or contact a Poison Control Centre immediately.

Drug Interactions

The concomitant use of certain herbal products, specifically those containing marshmallow herb, may enhance the topical anti-inflammatory effects of corticosteroids. This interaction is primarily pharmacodynamic in nature, as the marshmallow herb may potentiate the effects of the steroid.

Healthcare professionals should consider monitoring the therapeutic response when these agents are used together. Adjustments to the dosage of corticosteroids may be warranted based on the observed effects, ensuring that the patient receives optimal therapeutic benefit while minimizing the risk of potential side effects.

Packaging & NDC

Below are the non-prescription pack sizes of Restoral (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age are not recommended to use this medication. For adolescents aged 12 years and older, the recommended dosage is to apply the medication to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may require careful consideration when prescribing this medication. While specific data regarding dosage adjustments for geriatric patients are not provided, it is essential to monitor this population closely due to the potential for altered pharmacokinetics and increased sensitivity to medications.

Additionally, this medication is not recommended for children under 12 years of age, which underscores the importance of age-related considerations in prescribing practices. Healthcare providers should assess the overall health status and comorbidities of elderly patients to ensure safe and effective use. Regular monitoring for adverse effects and therapeutic efficacy is advised in this demographic.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised against the use of this medication while breastfeeding. It is important for lactating mothers to consult a healthcare professional prior to use to ensure the safety of both the mother and the breastfed infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Centre without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific product and the amount ingested; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management procedures.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize risks.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of these aspects remains incomplete.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Centre if the product is swallowed. It is crucial for patients to understand the potential risks associated with ingestion and the importance of prompt action in such situations.

Additionally, healthcare providers should emphasize the need to avoid contact with the eyes and mucous membranes. In the event of accidental contact, patients should be instructed to rinse the affected area with vegetable oil to mitigate any adverse effects. Clear communication regarding these precautions will help ensure patient safety and promote proper handling of the product.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its integrity and efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. The use of this medication is not recommended for children under 12 years of age. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Restoral, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)