Label: DHC SALICYLIC ACNE WASH- salicylic acid lotion
- NDC Code(s): 63433-383-00
- Packager: DHC USA Incorporated
- 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 28, 2022
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
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Inactive Ingredients
water, ammonium laureth sulfate, cetyl alcohol, cocamidopropyl betaine, glycol distearate, cocamide MEA, triethanolamine, phenoxyethanol, polyethylene, steareth-20, guar hydroxypropyltrimonium chloride, disodium EDTA, rosmarinus officinalis (rosemary) leaf oil, butylene glycol, allantoin, camellia sinensisleaf extract, royal jelly extract, scutellaria baicalensis root extract, houttuynia cordata extract, perilla ocymoides leaf extract, aloe barbadensis leaf extract
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 120 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
DHC SALICYLIC ACNE WASH
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63433-383 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 30 mg in 1.5 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B) Cetyl Alcohol (UNII: 936JST6JCN) Glycol Distearate (UNII: 13W7MDN21W) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Coco Monoethanolamide (UNII: C80684146D) Trolamine (UNII: 9O3K93S3TK) Phenoxyethanol (UNII: HIE492ZZ3T) High Density Polyethylene (UNII: UG00KM4WR7) Steareth-20 (UNII: L0Q8IK9E08) Guar Hydroxypropyltrimonium Chloride (1.7 Substituents per Saccharide) (UNII: B16G315W7A) Edetate Disodium (UNII: 7FLD91C86K) Rosemary Oil (UNII: 8LGU7VM393) Butylene Glycol (UNII: 3XUS85K0RA) Allantoin (UNII: 344S277G0Z) Green Tea Leaf (UNII: W2ZU1RY8B0) Royal Jelly (UNII: L497I37F0C) Scutellaria Lateriflora Top (UNII: C6CNB75R61) Houttuynia Cordata Flowering Top (UNII: RH041UUZ22) Perilla Frutescens Leaf (UNII: T4L5881Y68) Aloe Vera Leaf (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63433-383-00 1 in 1 CARTON 11/01/2018 1 120 mL in 1 BOTTLE, PLASTIC; 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 11/01/2018 Labeler - DHC USA Incorporated (004087554) Registrant - ABBE Laboratories, Inc. (781745286) Establishment Name Address ID/FEI Business Operations ABBE Laboratories, Inc. 781745286 MANUFACTURE(63433-383)