Label: ACNE SERUM- skin restoring acne serum gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 26, 2015

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  • ACTIVE INGREDIENT

    Salicylic Acid 1.0%

  • PURPOSE

    Acne medication

  • INDICATIONS & USAGE

    for treatment of acne

  • WARNINGS

    For external use only

  • WARNINGS AND PRECAUTIONS

    Flammable, keep away from open fire or flame

  • WHEN USING

    When using this product and other topical acne medications at the same time or immediately following use of this product, increased dryness of irritation of skin may occur. If this occurs, only one medication should be used unless directed by a doctor

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • INSTRUCTIONS FOR USE

    • Cleanse skin thoroughly before applying medication
    • Cover the affected area entirely up to 2 times daily
    • If excessinve dryness or peeling occurs, reduce usage to once a day or every other day
    • Recommended for daily use
  • INACTIVE INGREDIENT

    Water (Aqua), Alcohol Denat., Glycerin, Salix Nigra (Willow) Bark Extract,Vaccinium Myrtillus Fruit Extract,

    Pinus Nigra Bud/Needle Extract, Ribes Nigrum (Black Currant) Fruit Extract, Xanthan Gum, Saccharum Officinarum (Sugar Cane) Extract, Salix Alba (Willow) Bark Extract, Spiraea Ulmaria Flower Extract, Levulinic Acid, Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Sodium Levulinate, Citric Acid, Acer Saccharum (Sugar Maple) Extract

  • DOSAGE & ADMINISTRATION

    Topical gel

  • PRINCIPAL DISPLAY PANEL

    Acne Serum componentAcne Serum kit

  • INGREDIENTS AND APPEARANCE
    ACNE SERUM 
    skin restoring acne serum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61531-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Coloryellow (pinkish to yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61531-101-0130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/26/2015
    Labeler - Universal Packaging Systems, Inc. DBA: Paklab (790530976)
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