Label: ACNE SOLUTION- salicylic acid cream
- NDC Code(s): 78863-1220-2
- Packager: Noon Aesthetics M.R. Ltd
- 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 January 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- INDICATIONS & USAGE
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Warnings
- For external use only
- When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne at a time.
- Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.
Directions
Cleanse the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, if needed or as directed by a doctor. Start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
If bothersome dryness of peeling occurs, reduce application to one a day or every other day.
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Inactive Ingredients
Aqua, Methyl Perfluorobutyl Ether, Isododecane, Propanediol, Polymethylsilsesquioxane, Niacinamide, Glycerin, Polysilicone-11, Phenoxyethanol, Butylene Glycol, PPG-3 Benzyl Ether Myristate, Polysorbate 20, Triethanolamine, Hydroxyethylcellulose, Sodium Polyacrylate, Ethylhexyl Cocoate, Caprylyl Glycol, Decyl Glucoside, Cocamidopropyl Betaine, Hexylene Glycol, Sodium Sulfate, Sodium Benzoate, Oryza Sativa Bran Extract, Boswellia Serrata Extract, Honey Extract, Sodium Polyacrylate, Tea.
- Other information
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 g Bottle Carton
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INGREDIENTS AND APPEARANCE
ACNE SOLUTION
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78863-1220 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 0.15 g in 30 g Inactive Ingredients Ingredient Name Strength Methyl Perfluorobutyl Ether (UNII: H637A50B7U) Isododecane (UNII: A8289P68Y2) Water (UNII: 059QF0KO0R) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) Butylene Glycol (UNII: 3XUS85K0RA) Decyl Glucoside (UNII: Z17H97EA6Y) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) Niacinamide (UNII: 25X51I8RD4) Polysorbate 20 (UNII: 7T1F30V5YH) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Glycerin (UNII: PDC6A3C0OX) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) ETHYLHEXYL COCOATE (UNII: I1MPW273QS) PPG-3 Benzyl Ether Myristate (UNII: 8075L58MKO) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78863-1220-2 1 in 1 CARTON 05/01/2020 1 30 g in 1 BOTTLE, DISPENSING; 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 05/01/2020 Labeler - Noon Aesthetics M.R. Ltd (600185560) Establishment Name Address ID/FEI Business Operations NOON Aesthetics M.R Ltd 600185560 MANUFACTURE(78863-1220)
