Medicated Body

Description

No description information is available for the specified drug.

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 to avoid contact with the eyes and to refrain from applying the product to the genital area to prevent irritation or adverse effects.

In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if any of the following occur: worsening of the condition, persistent or increasing redness, irritation, swelling, or pain. Additionally, if symptoms do not improve within 7 days or if they resolve and then recur within a few days, medical advice should be sought promptly.

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 currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

For dosing, adults and children aged 2 years and older may apply the medication freely up to 3 or 4 times daily. However, for children under 2 years of age, it is advised to consult a physician before use.

Geriatric Use

There is no specific information 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 information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding or effects on breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

1. Assessment and Monitoring: Conduct a thorough evaluation of the patient's vital signs and mental status. Continuous monitoring may be necessary to detect any deterioration in the patient's condition.

2. Supportive Care: Initiate supportive measures as required, which may include airway management, oxygen supplementation, intravenous fluids, and other interventions tailored to the patient's needs.

3. Toxicology Consultation: Consider consulting a poison control center or a toxicologist for guidance on specific management strategies, including the use of antidotes if applicable.

4. Reporting: Document the incident and report any adverse effects or overdose cases to the appropriate regulatory authorities as per local guidelines.

Healthcare professionals are encouraged to familiarize themselves with the specific management protocols for the substances they prescribe or administer, as well as to stay updated on any emerging data regarding overdosage and its management.

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.

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 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 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)