Gold Bond Extra Strength

Description

GOLD BOND® EXTRA STRENGTH BODY LOTION is formulated to provide triple action relief for extra dry and itchy skin. This lotion is presented in a net weight of 14 ounces (396 grams).

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area up to three or four times daily. The specific frequency of application should be determined based on the severity of the condition and the response to treatment.

For children under 2 years of age, it is advised to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

Use of this product is contraindicated in the following situations:

Application is not recommended on deep or puncture wounds, animal bites, serious burns, or large areas of the body due to the potential for adverse effects and complications in these conditions.

Additionally, contact with the eyes or nose should be avoided to prevent irritation or injury. Prolonged use of this product is also contraindicated, as it may lead to unwanted side effects.

Warnings and Precautions

For external use only. This product is contraindicated for application on deep or puncture wounds, animal bites, serious burns, or large areas of the body.

When utilizing this product, it is imperative to avoid contact with the eyes and nose. Prolonged use is not recommended, and healthcare professionals should advise patients accordingly.

Patients should be instructed to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, if redness, irritation, swelling, or pain persists or intensifies, medical advice should be sought.

It is essential to keep this product out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on deep or puncture wounds, animal bites, serious burns, or large areas of the body.

During use, patients should take care to avoid contact with the eyes or nose and should refrain from prolonged use of the product. If a patient's condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to stop use and consult a healthcare professional. Additionally, if redness, irritation, swelling, or pain persists or increases, medical advice should be sought.

This product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended application is to the affected area up to 3 or 4 times daily.

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 should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for use on deep or puncture wounds, animal bites, serious burns, or large areas of the body. It is important to emphasize that if the patient's condition worsens, they should stop using the product and consult a doctor. Additionally, patients should be instructed to seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

Healthcare providers should also caution patients to discontinue use and consult a doctor if they experience persistent or increasing redness, irritation, swelling, or pain. While using this product, patients should be advised to avoid contact with the eyes or nose and to refrain from prolonged use.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from excessive heat, and must not be frozen. After opening, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being up to 3 or 4 times daily. For children under 2 years of age, it is advised to consult a doctor before use. 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 Gold Bond Extra Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)