SA OIL FREE CREAM (SALICYLIC ACID CREAM) CREAM [ESSAY COSMETICS GROUP LLC]

SA OIL FREE CREAM (SALICYLIC ACID CREAM) CREAM [ESSAY COSMETICS GROUP LLC]
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NDC 72900-882-70
Set ID 81514060-eddd-c598-e053-2a91aa0a03ba
Category HUMAN OTC DRUG LABEL
Packager Essay Cosmetics Group LLC
Generic Name
Product Class
Product Number
Application Number PART333D
  • Active Ingredient

    Acne medication, 1% Salicylic Acid

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  • PURPOSE

    Acne Medication

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  • Use

    Use ■ for treatmant of acne

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  • WARNINGS

    Warnings ■ for external use only ■ 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

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  • INSTRUCTIONS FOR USE

    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 INGREDIENT

    Inactive ingredients Water, Glycerin, Dimethicone, Cetyl Alcohol, Propanediol, Isopropyl Myristate, Glyceryl Stearate, PEG-100 Stearate, Behentrimonium Methosulfate, Bisabolol, Cyclomethicone, Allantoin, Butylene Glycol, Tocopheryl Acetate, Propylene Glycol, Disodium EDTA, Diazolidinyl Urea, Iodopropynyl Butylcarbamate

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  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center immediately.

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  • DOSAGE & ADMINISTRATION

    ● 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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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    SA OIL FREE CREAM 
    salicylic acid cream cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:72900-882
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 g  in 0.5 g
    Inactive Ingredients
    Ingredient Name Strength
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    1,2-PROPANEDIOL, 1-BENZOATE (UNII: K4K90ZQ89N)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72900-882-70 0.5 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/28/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 02/28/2019
    Labeler - Essay Cosmetics Group LLC (085448126)
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