Drug Facts Active Ingredients
Menthol 0.15 %
Medicated Body Powder
FDA Label NDC 30400-506
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jell Pharmaceuticals Pvt Ltd for the product Medicated Body (NDC 30400-506). 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 drug facts active ingredients, purpose, uses, warnings, when usin this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Uses
for the temporary relief of the pain and itch associated with
- minor cuts
- scrapes
- sunburn
- insect bites
- prickly heat
- rashes
- minor burns
- minor skin irritations
- dries the oozing of poison ivy, oak and sumac.
Warnings
For external use only
When Usin This Product
Avoid contact with eyes. Not for genital area.
Stop Use And Ask A Doctor If
- condition worsens
- Redness, irritation, swelling or pain persist or increases
- symptoms do not get better within 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- adults and children 2 years of age and over, apply freely up to 3 or 4 times daily
- Children under 2 years: consult a physician
- for best results, dry skin thoroughly before use
Inactive Ingredients
acacia seyl gum, eucalyptol, methyl salicylate, salicylic acid, sodium bicarbonate, thymol, tricalciun phosphate, zea mays (corn stach), zinc oxide, zinc stearate
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