Label: PIMPLE CORRECT 2% SALICYLIC ACID ACNE TREATMENT- salicylic acid gel
- NDC Code(s): 73381-003-00
- Packager: Hero Cosmetics, Inc.
- 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 December 2, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
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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 medication at a time.
- avoid contact with eyes. If contact occurs, rinse thoroughly with water.
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Directions
- Cleanse 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, 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 or peeling occurs, reduce application to once a day or every other day.
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Inactive ingredients
water/aqua, butylene glycol, nigella sativa seed extract, isopentyldiol, sodium polyacrylate, lactic acid, hydroxyethylcellulose, melaleuca alternifolia (tea tree) leaf oil, niacinamide, polydextrose, caffeine, maltodextrin, xanthan gum, allantoin, ceratonia siliqua gum, sodium hydroxide, opuntia ficus-indica stem extract, agar, aloe barbadensis leaf juice powder, glycerin, biosaccharide gum-1, melia azadirachta leaf extract, 1,2-hexanediol, caprylyl glycol, sodium levulinate, glyceryl caprylate, tocopherol, tocopheryl acetate, coccinia indica fruit extract, disodium phosphate, polysorbate 60, ammonium acryloyldimethyltaurate/VP copolymer, gellan gum, sodium anisate, aloe barbadensis flower extract, solanum melongena fruit extract, azelaic acid, corallina officinalis extract, ocimum sanctum leaf extract, simmondsia chinensis seed oil, sodium phosphate, sebacic acid, limonene
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INGREDIENTS AND APPEARANCE
PIMPLE CORRECT 2% SALICYLIC ACID ACNE TREATMENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73381-003 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 LIMONENE, (+)- (UNII: GFD7C86Q1W) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NIGELLA SATIVA SEED (UNII: 4LVZ0Z0ITT) ISOPENTYLDIOL (UNII: 19NOL5474Q) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) TEA TREE OIL (UNII: VIF565UC2G) NIACINAMIDE (UNII: 25X51I8RD4) POLYDEXTROSE (UNII: VH2XOU12IE) CAFFEINE (UNII: 3G6A5W338E) MALTODEXTRIN (UNII: 7CVR7L4A2D) XANTHAN GUM (UNII: TTV12P4NEE) ALLANTOIN (UNII: 344S277G0Z) LOCUST BEAN GUM (UNII: V4716MY704) SODIUM HYDROXIDE (UNII: 55X04QC32I) OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL) AGAR, UNSPECIFIED (UNII: 89T13OHQ2B) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM LEVULINATE (UNII: VK44E1MQU8) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) POLYSORBATE 60 (UNII: CAL22UVI4M) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D) SODIUM ANISATE (UNII: F9WFJ28MV9) ALOE VERA FLOWER (UNII: 575DY8C1ER) AZELAIC ACID (UNII: F2VW3D43YT) CORALLINA OFFICINALIS (UNII: 4004498D06) HOLY BASIL LEAF (UNII: SCJ765569P) JOJOBA OIL (UNII: 724GKU717M) SODIUM PHOSPHATE (UNII: SE337SVY37) SEBACIC ACID (UNII: 97AN39ICTC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73381-003-00 1 in 1 BOX 12/01/2022 09/14/2024 1 10 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 12/01/2022 09/14/2024 Labeler - Hero Cosmetics, Inc. (053668306)
