Otc - Active Ingredient
Active Ingredients
Menthol 0.15%
Zinc Oxide 1.0%
Medicated Body
FDA Label NDC 52000-024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Medicated Body (NDC 52000-024). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Anti-itch
Indications & Usage
Uses
For the temporary relief from pain and itching associated with minor cuts and burns, sunburn, scrapes, insect bites, and other minor skin irritation. Also for drying up poison oak, which helps control the growth of fungi associated with athlete's foot and jock itch.
Warnings
Warning
For external use only.
Otc - When Using
Avoid contact with eyes.
Otc - Ask Doctor
If symptoms persist more than 7 days, worsen with use or return within a few days of cleaning up, discontinue use of this product and consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Dosage & Administration
Directions
Use after shower, bath or exercise. Use in footwear and on feet. Dry skin completely before applying. For adults and children over 2 years; apply to affected area not more than 3 or 4 times daily. Children Under 2 Years; Consult a doctor.
Inactive Ingredient
Inactive Ingredients
talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, zinc stearate.
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL
MEDICATED BODY POWDER
NET WT. 10 OZ. (283g)
Product Label (Medicated Body Powder)
* Please review the disclaimer below.
