SA OIL FREE SERUM (SALICYLIC ACID SERUM) GEL [ESSAY COSMETICS GROUP, LLC]

SA OIL FREE SERUM (SALICYLIC ACID SERUM) GEL [ESSAY COSMETICS GROUP, LLC]
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NDC 72900-008-80
Set ID 826fa846-59ef-c035-e053-2991aa0a4bed
Category HUMAN OTC DRUG LABEL
Packager Essay Cosmetics Group, LLC
Generic Name
Product Class
Product Number
Application Number PART333D
  • Active Ingredient

    Active Ingredient 1.2% Salicylic Acid

  • Purpose

    Acne Medication

  • INDICATIONS & USAGE

    ■ apply evenly to the affected area one to two times daily

  • 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

    Inactive ingredients Water, PEG-7 Glyceryl Cocoate, Propanediol, Glycerin, PEG-40 Hydrogenated Castor Oil, Cocamidopropyl dimethylamine, Glycine Betaine, Dipotassium Glycyrrhizinate, Bisabolol, Allantoin, Xanthan Gum, Hydroxyethylcellulose, Sodium Gluconate, Propylene Glycol, Diazolidinyl Urea, Lodopropynyl Butylcarbamate, Sodium Hydroxide

  • KEEP OUT OF REACH OF CHILDREN

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

  • 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 pealing occurs, reduce application to once a day or every other day

  • WARNINGS

    Warnings ■ 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

    .

  • Principal Display Panel

    SA Oil Free Serum

  • INGREDIENTS AND APPEARANCE
    SA OIL FREE SERUM 
    salicylic acid serum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72900-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.72 g  in 0.72 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    BETAINE (UNII: 3SCV180C9W)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72900-008-800.72 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/28/2019
    Labeler - Essay Cosmetics Group, LLC (085448126)

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