Medicated Body Extra Strength

Description

This medicated body powder, identified by NDC 49035-295-10, is marketed under the equate™ brand and is formulated to provide 4X relief for various skin irritations. It contains menthol at a concentration of 0.15%, which contributes to its cooling effect. The powder is designed to relieve itching, cool the skin, absorb moisture, and help protect the skin. It is packaged in a net weight of 10 ounces (283 grams) and is a product of India. This formulation is comparable to the active ingredients found in GoldBond® Medicated Body Powder.

Uses and Indications

This drug is indicated for the temporary relief of pain and itch associated with minor cuts, scrapes, sunburn, insect bites, prickly heat, rashes, minor burns, and minor skin irritations. Additionally, it is effective in drying the oozing of poison ivy, oak, and sumac.

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

Dosage and Administration

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

For optimal results, it is important to ensure that the skin is thoroughly dried before application. This preparation step may enhance the effectiveness of the treatment.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with the eyes should be strictly avoided due to the potential for irritation or injury. Additionally, the product is not intended for use in the genital area, as this may lead to adverse effects.

Warnings and Precautions

For external use only. It is imperative that this product is not ingested.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens; there is persistent or increasing redness, irritation, swelling, or pain; or if symptoms do not improve within 7 days, or if they resolve and then recur within a few days.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center without delay.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if the condition worsens, if redness, irritation, swelling, or pain persists or increases, or if symptoms do not improve within 7 days or clear up and then recur within a few days.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Medicated Body Extra Strength (menthol 0.80%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may use the product, with a recommended application frequency of up to 3 or 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

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

The available data does not specifically address the use of this medication during pregnancy. There are no documented safety concerns related to pregnancy, and no dosage modifications are recommended for pregnant patients. Additionally, no special precautions regarding the use of this medication in pregnant individuals have been outlined. Healthcare professionals should consider the absence of specific information when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement standard supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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

Reports of adverse reactions and side effects have been received through voluntary submissions and surveillance programs. For inquiries or to report any undesired reactions, individuals are encouraged to contact the designated support line at 1-888-287-1915.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes and inform patients that the medication is not intended for use in the genital area. This guidance is crucial to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature, ensuring that it is protected from excessive heat to maintain its integrity. The container should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, it is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of up to three or four times daily for adults and children aged 2 years and older. For children under 2 years, consultation with a physician is advised. Clinicians should counsel patients to ensure that the skin is thoroughly dried before application for optimal results. In the event of accidental ingestion, patients are instructed to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)