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Talc-Free Medicated Body

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Active ingredient
Menthol 0.15 g/100 g
Other brand names
Dosage form
Powder
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
February 28, 2024
Active ingredient
Menthol 0.15 g/100 g
Other brand names
Dosage form
Powder
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
February 28, 2024
Manufacturer
Davion, Inc
Registration number
M017
NDC root
42669-209

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If you are a consumer or patient please visit this version.

Drug Overview

This product is a talc-free medicated body powder designed to provide triple relief for your skin. It helps absorb moisture, soothes irritation, and relieves itching. You can use it for temporary relief from pain and itch associated with minor cuts, sunburn, insect bites, scrapes, minor burns, and other minor skin irritations.

With its gentle formula, this body powder aims to keep your skin comfortable and dry, making it a helpful addition to your skincare routine, especially during warmer weather or after outdoor activities.

Uses

You can use this medication for the temporary relief of pain and itching caused by various minor skin issues. It is effective for treating discomfort associated with minor cuts, scrapes, sunburn, insect bites, minor burns, and other minor skin irritations.

This product is designed to help soothe your skin and provide quick relief, making it a handy option for everyday skin mishaps.

Dosage and Administration

Before you start using this medication, make sure to remove the seal located beneath the cap. If the seal is broken or missing, do not use the product.

For adults and children aged 2 years and older, you can apply the medication freely up to 3 or 4 times a day. If your child is under 2 years old, it’s important to consult a doctor before use. For the best results, ensure that the skin is completely dry before applying the medication.

What to Avoid

It's important to be aware of certain guidelines when using this medication. If your condition worsens or if your symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using the medication and consult your doctor. This ensures that you receive the appropriate care and support for your health needs.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always prioritize your health and safety by following the recommended instructions.

Side Effects

It's important to use this product only on the skin and to avoid getting it in your eyes. If your condition worsens, if symptoms last more than seven days, or if they improve and then return within a few days, you should stop using the product and consult a doctor.

Keep this product out of reach of children. If a child accidentally ingests it, seek medical help or contact a poison control center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes. If you notice that your condition worsens, or if your symptoms last longer than 7 days or return after clearing up, it’s important to stop using the product and consult your doctor.

In the event of accidental ingestion, seek emergency medical help immediately or contact a poison control center. Your safety is a priority, so please take these precautions seriously.

Overdose

If you or someone else accidentally takes too much of a medication, it's important to act quickly. You should seek medical help immediately or contact a poison control center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication.

Remember, it's always better to be safe and get professional advice if you suspect an overdose. Don't hesitate to reach out for help.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the drug insert for TALC-FREE MEDICATED BODY menthol powder does not provide specific information about its use during nursing. This means there are no established guidelines or safety data regarding how this product may affect you or your baby while breastfeeding.

As always, it's a good idea to consult with your healthcare provider before using any new products to ensure they are safe for you and your nursing infant.

Pediatric Use

If you have a child under 2 years old, it's important to consult with a doctor before using this medication. For children aged 2 years and older, you can apply the medication freely, but limit it to 3 or 4 times a day. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients with liver impairment.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep the container tightly closed. It's important to protect it from moisture, as exposure can affect its quality. Once you open the container, please remember to discard any remaining product, as it should not be reused. Following these guidelines will help maintain safety and effectiveness.

Additional Information

No further information is available.

FAQ

What is the general description of this product?

This is a talc-free medicated body powder with a triple relief formula that helps absorb moisture, soothe skin, and relieve itching.

What conditions does this product temporarily relieve?

It provides temporary relief of pain and itch associated with minor cuts, sunburn, insect bites, scrapes, minor burns, and minor skin irritations.

How should I use this product?

For adults and children 2 years and older, apply freely up to 3 or 4 times daily. For children under 2 years, consult a doctor.

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with eyes and keep out of reach of children.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

How should I store this product?

Store at room temperature, keep the container tightly closed, and protect it from moisture.

Is there any information regarding use during pregnancy or nursing?

No specific information regarding safety concerns or precautions during pregnancy or nursing is provided.

What should I do in case of accidental ingestion?

Get medical help or contact a poison control center right away if accidental ingestion occurs.

Packaging Info

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

Packaging configurations for Talc-Free Medicated Body.
Details

Drug Information (PDF)

This file contains official product information for Talc-Free Medicated Body, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

This product is identified by NDC 42669-209-01 and is a talc-free medicated body powder formulated to provide triple relief. It is designed to absorb moisture effectively while soothing the skin and alleviating itching. The product is comparable to the active ingredient found in Gold Bond® Medicated Body Powder*. It is available in a net weight of 10 ounces (283 grams).

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

Before the first use, the seal beneath the cap must be removed. The product should not be used if the seal is broken or missing.

For adults and children aged 2 years and older, the recommended application is to apply freely up to 3 or 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

For optimal results, it is important to ensure that the skin is thoroughly dried before application.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition worsens or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

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 advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These actions are crucial to ensure appropriate management of the patient's condition.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients or caregivers are advised to contact a poison control center or seek emergency medical help without delay. This precaution is essential to mitigate potential health risks associated with ingestion.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than 7 days or clear up and then occur again within a few days, it is advised to stop use and consult a doctor.

Additionally, it is crucial to keep the product out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center is recommended.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Talc-Free Medicated Body.
Details

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

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There is no specific information regarding the use of TALC-FREE MEDICATED BODY menthol powder in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers on the use of this product. The potential effects on breastfed infants have not been established.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of accidental ingestion, it is imperative to seek immediate medical assistance or contact a poison control center. Prompt action is crucial to mitigate potential risks associated with overdosage.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of overdosage should be guided by the severity of symptoms and the specific substance ingested. Supportive care and symptomatic treatment may be necessary, and healthcare providers should follow established protocols for the management of overdose cases.

It is critical to monitor the patient closely and provide appropriate interventions as needed, ensuring that all actions taken are in accordance with current clinical guidelines and recommendations.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

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 center in the event of accidental ingestion of the medication. It is important for patients to understand the urgency of this action to ensure their safety and well-being.

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, ensuring that it is protected from moisture. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Talc-Free Medicated Body, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Talc-Free Medicated Body, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.