Label: AGE DEFYING BLEMISH TREATMENT- salicylic acid cream

  • NDC Code(s): 44717-148-01, 44717-148-02
  • Packager: Wasatch Product Development, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/14

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  • ACTIVE INGREDIENT

    Active Ingredient        Purpose

    Salicylic Acid 2%          Acne Treatment

    Uses

    For the treatment of acne

    Dries up acne pimples

    Helps prevent new acne pimples

    Keep out of reach of children. If swallowed, get medical help or contact a a Poison Control Center right away.

    Stop use and ask a doctor if irritation becomes severe.

    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. If irritation occurs, start with one application daily, then gradually increase to two or three times daily if needed or directed by a doctor.

    If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

    Directions

    Clean the skin thoroughly before applying this product

    Cover the entire affected area with a thin layer one to three times daily

    Becuase excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three daily if needed or directed by a doctor. 

    Inactive ingredients SD Alcohol 40-B, Ethoxydiglycol, Water, Glycerin, Azelaic Acid, Nylon-10/10, Polyacrylate Crosspolymer-6, Propanediol, Betaine, PEG-8/SMDI Copolymer, PEG-12 Dimethicone, Palmitoyl Tripeptide-38, Lens Esculenta (Lentil) Seed Extract, Tetrahexyldecyl Ascorbate, Dipotassium Glycyrrhizinate, Hydroxypropyl Cyclodextrin, Triethanolamine, Fragrance

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  • PRINCIPAL DISPLAY PANEL

    Clear

    Age Defying Treatment

    2% Salicylic Acid

    Acne Treatment

    4% Azelaic Acid

    Skin Conditioner

    30 ML/ 1 FL OZ

    carton label

    bottle label

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  • INGREDIENTS AND APPEARANCE
    AGE DEFYING BLEMISH TREATMENT 
    salicylic acid cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:44717-148
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    DIETHYLENE GLYCOL MONOETHYL ETHER  
    WATER  
    GLYCERIN  
    AZELAIC ACID  
    PROPANEDIOL  
    BETAINE  
    PEG-8/SMDI COPOLYMER  
    PEG-12 DIMETHICONE (300 CST)  
    LENTIL  
    TETRAHEXYLDECYL ASCORBATE  
    GLYCYRRHIZINATE DIPOTASSIUM  
    HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44717-148-02 1 in 1 CARTON
    1 NDC:44717-148-01 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 10/24/2013
    Labeler - Wasatch Product Development, LLC (962452533)
    Registrant - Wasatch Product Development, LLC (962452533)
    Establishment
    Name Address ID/FEI Business Operations
    Wasatch Product Development, LLC 962452533 manufacture(44717-148)
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