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

    Drug Facts

  • Active ingredients

    SALICYLIC ACID 0.5%

  • Purpose

    Acne medication

  • Uses

    • For the treatment of acne
  • 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.

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • 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.
  • 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

    cap contains natural materials that may change color/texture over time. This doesn't affect product quality. Wipe any liquid or dirt off the cap and store in a dry area.

  • Questions or comments?

    Call toll free 1-800-906-7503

  • PRINCIPAL DISPLAY PANEL - 20 mL Tube Carton

    WASO
    SHISEIDO
    GINZA TOKYO

    KOSHIRICE

    ACNE CALMING
    TREATMENT

    + SALICYLIC ACID

    SPOT CLEAR

    RICE
    HYOGO

    20mL NET WT. .7 OZ.

    PRINCIPAL DISPLAY PANEL - 20 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-615
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.1 g  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-615-601 in 1 CARTON01/01/2021
    120 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00601/01/2021
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shiseido America Inc.782677132ANALYSIS(58411-615) , MANUFACTURE(58411-615)
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