Restoral

Description

Restoral is a topical analgesic ointment formulated for the relief of pain. It is available in two net weights: 54.1 grams (1.91 ounces) and 13.5 grams (0.47 ounces). The product is designed for application to the skin, providing localized analgesic effects.

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 prescribing or recommending concurrent use of topical steroids.

Contact with eyes and mucous membranes should be avoided. In the event of accidental contact, it is advised 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 exacerbate irritation or 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 the Poison Control Centre should be contacted without delay.

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. The product is intended 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 with known allergies to marshmallow root or chickweed. Pregnant or breastfeeding patients should seek advice from a healthcare professional before using this product.

Additionally, it is crucial to keep this product out of reach of children. If the product is swallowed, immediate medical assistance should be sought, or contact with a Poison Control Centre should be made without delay.

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 clinical 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. Caution should be exercised when considering treatment in this age group, ensuring adherence to the specified dosing guidelines.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Restoral menthol ointment. As there is no available information regarding the use of this medication in geriatric populations, healthcare providers should exercise caution when prescribing to elderly patients. It is advisable to monitor these patients closely for any adverse effects or unusual responses to treatment, given the general considerations for pharmacotherapy in this age group.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

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 safety for both the mother and the breastfed infant.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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.

Management procedures will typically involve supportive care and symptomatic treatment, tailored to the individual case. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

The use of this product is contraindicated in pregnant or breastfeeding individuals due to potential teratogenic effects. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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 important to inform patients that the product should only be applied to intact skin and not on wounds or damaged skin.

Patients should be made aware of the potential for allergic reactions, particularly if they have a known allergy to marshmallow root or chickweed. They should be instructed to monitor their condition closely and to report any worsening of symptoms or if symptoms persist for more than 7 days. Additionally, patients should be cautioned that if symptoms improve and then recur within a few days, they should seek further medical advice.

Healthcare providers should emphasize the importance of avoiding 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.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. The container must be kept tightly closed to prevent contamination and degradation. Additionally, the product should be protected from light exposure to ensure optimal stability. Once opened, the product must be discarded to avoid any potential safety risks.

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)