Otc - Active Ingredient
Active ingredient Purpose
Salicylic acid 2%.........................................................Acne medication
Family Care Ultra Acne Treatment
FDA Label NDC 65923-587
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care Ultra Acne Treatment (NDC 65923-587). 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, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
for the treatment of acne
Warnings
Warnings
For external use only
Flammable keep away from extreme heat or open flame
Otc - When Using
When using this product
- avoid contact with the eyes. If product gets into the eyse rinse thoroughly with water
- with other topical acne medications, at the same time or immediately following use of this product, may increase dryness or irritation of the skin. If this occurs, only one acne medication should be used unless directed by your doctor
- limit use to the face and neck
Otc - Stop Use
Stop use and ask a doctor if skin or eye irritation develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately
Indications & Usage
Directions
- cleanse the skin thoroughly before applying medication
- cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 applications daily if needed
or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a dy or every other day
Storage And Handling
Other informatiom
store in a cool dry place
Inactive Ingredient
Inactive ingredients ethanol, water, glycerin, sorbitol, polysorbate 20, hydroxyethyl cellulose, decolorized alove vera leaf, helichrysum italicum flover, L-menthol, sodium hydroxide, fragrance, methylparaben, edetate disodium, propylparaben
Dosage & Administration
Distributed by:
United Exchange Corp.
17211 Valley View Ave.
Cerritos, CA 90703 U.S.A.
Made in Korea
Package Label.Principal Display Panel
Image Description (587.2)
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