Gold Bond Medicated Extra Strength Body

Description

GOLDBOND EXTRA STRENGTH BODY POWDER is a topical powder formulation designed for external use. It is packaged in a net weight of 10 ounces (283 grams). The product is intended to provide relief from discomfort associated with skin irritations and moisture.

Uses and Indications

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

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 frequency is up to 3 or 4 times daily. It is essential to ensure that the skin is thoroughly dried prior to application to achieve optimal results.

For children under the age of 2 years, it is advised to consult a physician before use to determine appropriate dosing and administration.

Contraindications

Use is contraindicated in patients with a known hypersensitivity to any component of the product. Additionally, contact with the eyes should be strictly avoided to prevent irritation or injury.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if redness, irritation, swelling, or pain persists or increases, patients should be instructed to stop use and consult a healthcare provider.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. Care should be taken to avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor.

Additionally, if any redness, irritation, swelling, or pain persists or increases, medical advice should be sought. It is important to keep this product out of reach of children. In the case of accidental ingestion, immediate medical assistance should be obtained or contact with a Poison Control Center should be made.

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 Medicated Extra Strength Body (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 product may be applied freely up to 3 or 4 times daily.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Gold Bond Medicated Extra Strength Body Powder during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There is no specific information regarding the use of Gold Bond Medicated Extra Strength Body Powder in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. The specific symptoms may vary depending on the substance involved; therefore, a thorough assessment by medical personnel is essential.

Management procedures will typically involve supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous monitoring and evaluation may be necessary to ensure patient safety and effective management of any complications that arise from the overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 instructed to discontinue use and consult a doctor if their condition worsens. Additionally, they should be informed to stop using the product and seek medical advice if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

It is important to inform patients that they should stop using the product and consult a healthcare professional if they experience any redness, irritation, swelling, or pain that persists or increases. Furthermore, patients should be cautioned to avoid contact with their eyes while using this product.

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. To ensure safety, the product should be kept out of reach of children. Any unused portion should be discarded after opening to prevent potential contamination or degradation.

Additional Clinical Information

The medication is administered topically, with the recommended frequency of application being up to three or four times daily for adults and children aged 2 years and older. For children under 2 years, 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 Medicated Extra Strength Body, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)