Active Ingredients
Zinc oxide (12.5%)
Herbal Power Alternative
FDA Label NDC 81386-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bells & More Inc for the product Herbal Power Alternative (NDC 81386-003). 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 ingredients, purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Uses
Dries oozing of poison ivy, oak, and temporarily relieves the pain and itch associated with:
- minor skin irritations, cuts, scrapes, burns
- insect bites, rashes, jock itch
- sunburn, diaper rash, chafing dermatitis
- decubital ulcers
Warnings
- For external use only
- Avoid contact with eyes. Not for genital area.
Otc - Stop Use
Stop use and ask a doctor if condition worsens or symptoms do not improve within 7 days or clear up and occur again within a few days
Otc - 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 right away.
Directions
- Adults and children 2 years and older: apply freely up to 3 or 4 times daily.
- Under 2 years: ask a doctor before using.
- For best results, dry skin thoroughly before use.
Inactive Ingredients
Boric acid, Carbolic acid, Talc
Principal Display Panel
57 g NDC: 81386-003-57
Zinc Oxide Powder 57 G (Powder Final)
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