Label: PORE RELEASE 2 SALICYLIC ACID ACNE TREATMENT- salicylic acid liquid
- NDC Code(s): 73381-001-00
- Packager: Hero Cosmetics, Inc.
- Category: HUMAN OTC DRUG LABEL
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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- 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, flush thoroughly with water.
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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, 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, gluconolactone, arginine, glycolic acid, aloe barbadensis leaf juice, nelumbo nucifera root water, glycerin, hydrolyzed gardenia florida extract, biosaccharide gum-1, sodium levulinate, glyceryl caprylate, maltodextrin, sodium anisate, sodium hydroxide, potassium sorbate, sodium benzoate, citric acid
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INGREDIENTS AND APPEARANCE
PORE RELEASE 2 SALICYLIC ACID ACNE TREATMENT
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73381-001 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) GLUCONOLACTONE (UNII: WQ29KQ9POT) ARGININE (UNII: 94ZLA3W45F) GLYCOLIC ACID (UNII: 0WT12SX38S) ALOE VERA LEAF (UNII: ZY81Z83H0X) NELUMBO NUCIFERA ROOT OIL (UNII: 382005USDH) GLYCERIN (UNII: PDC6A3C0OX) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) SODIUM LEVULINATE (UNII: VK44E1MQU8) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM ANISATE (UNII: F9WFJ28MV9) SODIUM HYDROXIDE (UNII: 55X04QC32I) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73381-001-00 1 in 1 BOX 12/01/2022 11/21/2024 1 100 mL in 1 BOTTLE; 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 12/01/2022 11/21/2024 Labeler - Hero Cosmetics, Inc. (053668306)