Active Ingredient
Menthol 0.80%
Healthwise Medicated Extra Body Powder 10 Oz Powder
FDA Label NDC 71101-047
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise Medicated Extra Body Powder 10 Oz (NDC 71101-047). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and consult 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 irritation ■ dries the oozing of poison ivy, oak, and sumac.
Warnings
For external use only
When Using This Product
Avoid contact with eyes.
Stop Use And Consult A Doctor If
■ Condition worsens ■ Redness, irritation, swelling or pain persists 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
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 seyal gum, eucalyptus oil, methyl salicylate, salicylic acid, sodium bicarbonate, thymol, tricalcium phosphate, zea mays (corn) starch, zinc oxide, zinc stearate
Questions Or Comments
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