Label: SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENT- salicylic acid gel
- NDC Code(s): 58411-615-60
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 18, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- clean 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▪BUTYLENE GLYCOL▪DIPROPYLENE GLYCOL▪DIMETHICONE▪PEG-6▪PEG-32▪PEG-240/HDI COPOLYMER BIS-DECYLTETRADECETH-20 ETHER▪ERYTHRITOL▪GLYCERIN▪PEG/PPG-14/7 DIMETHYL ETHER▪DIPOTASSIUM GLYCYRRHIZATE▪PAEONIA ALBIFLORA ROOT EXTRACT▪HYDROLYZED RICE EXTRACT▪CITRUS DEPRESSA PEEL EXTRACT▪ISOSTEARYL ALCOHOL▪CARBOMER▪POTASSIUM HYDROXIDE▪SODIUM METAPHOSPHATE▪ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER▪BHT▪PHENOXYETHANOL▪BENZOIC ACID▪ <M095042-811>
- Other information
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- PRINCIPAL DISPLAY PANEL - 20 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-615 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.1 g in 20 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A) GLYCERIN (UNII: PDC6A3C0OX) ERYTHRITOL (UNII: RA96B954X6) PHENOXYETHANOL (UNII: HIE492ZZ3T) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) TANGERINE PEEL (UNII: JU3D414057) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZOIC ACID (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-615-60 1 in 1 CARTON 01/01/2021 1 20 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 DRUG M006 01/01/2021 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations Shiseido America Inc. 782677132 ANALYSIS(58411-615) , MANUFACTURE(58411-615)