Medicated Body

Description

Equate Medicated Body Powder Original is a topical formulation designed for the management of skin irritation. The product is intended for use in areas prone to moisture and friction. It is formulated to provide a soothing effect and help absorb excess moisture, thereby reducing the risk of skin discomfort. The effective time for this product is noted as September 1, 2020.

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 applied solely to the skin and not ingested.

General precautions must be observed 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. Monitoring for these signs is essential to ensure patient safety and effective management of the condition.

Side Effects

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

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 (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may 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.

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

There is no specific information regarding the use of Equated Medicated Body Powder (menthol powder) during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should exercise caution when recommending this product to women of childbearing potential, as the absence of data does not preclude potential risks. It is advisable to consider the benefits and risks of using this product in pregnant patients on a case-by-case basis, given the lack of dosage modifications or special precautions outlined in the prescribing information.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider 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 initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose situation effectively.

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 question.

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. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens. Additionally, they should stop using the product and seek medical advice if they experience persistent or increasing redness, irritation, swelling, or pain.

It is important for patients to be aware that if their symptoms do not improve within 7 days, or if symptoms clear up and then recur within a few days, they should stop use and consult a healthcare professional.

While using this product, patients should be cautioned to avoid contact with the eyes and to refrain from applying it to the genital area.

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 medication is administered topically, with a recommended application frequency of up to 3 or 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a physician prior to use. 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 Medicated Body, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)