Label: FAMILY CARE ULTRA ACNE TREATMENT- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-587-12 - Packager: United Exchange Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 17, 2017
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
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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
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAMILY CARE ULTRA ACNE TREATMENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-587 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALOE VERA LEAF (UNII: ZY81Z83H0X) HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24) MENTHOL (UNII: L7T10EIP3A) SODIUM HYDROXIDE (UNII: 55X04QC32I) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-587-12 1 in 1 BOX 02/17/2017 1 11.9 g in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/17/2017 Labeler - United Exchange Corp. (840130579)