Label: CVS ACNE SPOT TREATMENT- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-055-56 - Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 July 10, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
Flammable, keep away from open fire or flame
When using this product and other topical acne medications at the same time
or immediately following use of this product, increased dryness or irritation of the skin
may occur. If this occurs, only one medication should be used unless directed by a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water. - DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients
alcohol, butylene glycol, capryloyl glycine, cedrus atlantic bark extract, cinnamomum
zeylanicum bark extract, fragrance, glycerin, hexylene glycol, hydroxyethylcellulose,
methylparaben, portulica oleracea extract, propylene glycol, propylparaben, purified water,
sarcosine, sodium citrate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CVS ACNE SPOT TREATMENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-055 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MANGANESE GLUCONATE (UNII: 9YY2F980SV) OLIVE OIL (UNII: 6UYK2W1W1E) CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF) GLYCERIN (UNII: PDC6A3C0OX) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PURSLANE (UNII: M6S840WXG5) ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) ALCOHOL (UNII: 3K9958V90M) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: ZYD53NBL45) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-055-56 1 in 1 CARTON 1 22 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333D 07/10/2010 Labeler - CVS Pharmacy (062312574) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture