Restoral

Description

No description information is available for the drug.

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. The presence of marshmallow herb may enhance the topical anti-inflammatory effects of steroids, necessitating caution in concurrent use.

General precautions should be observed to avoid contact with the eyes and mucous membranes. In the event of accidental contact, it is recommended to rinse the affected area with vegetable oil.

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

In cases where the product is ingested, immediate medical assistance should be sought, or contact with a Poison Control Centre is advised.

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

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 product. For adolescents aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Healthcare professionals should advise caregivers to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Centre is advised.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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.

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.

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

If pregnant or breast-feeding, it is advised to consult a health professional before use. No non-teratogenic effects have been specified. 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.

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 configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness.

To ensure safety, the product must be kept away from fire or flame, and it should be stored out of reach of children to prevent accidental ingestion. Additionally, once opened, the product should be discarded to avoid any potential risks associated with prolonged exposure to air or contamination.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 12 years and older. There are no additional details available regarding laboratory tests, abuse information, 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)