Medicated Body Extra Strength

Description

No description information is available for the 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 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 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 Extra Strength (menthol 0.80%). 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 the Poison Control Center (1-800-222-1222) should be contacted.

For children aged 2 years and older, the medication may be applied freely up to 3 or 4 times daily. However, 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

There is no specific information available 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 using this medication.

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

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 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 depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further 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 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 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 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 to achieve optimal results.

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)