Label: ASEPXIA LIQUID ACNE CLEANSER- salicylic acid lotion

  • 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 September 26, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 1.0%

  • Purpose

    Acne treatment

  • Uses

    • Helps clear up acne blemishes
    • Penetrates pores to control acne blemishes
    • Helps prevent new acne blemishes from forming
  • 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.
    • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor

    • If excessive skin irritation occurs.

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

  • Directions

    • Use daily on skin prone to acne.
    • Apply to wet skin with a clean wash cloth or body puff. Rinse thoroughly and pat dry with a clean towel.
    • If bothersome dryness or peeling occurs, reduce application to every other day.
  • Other information

    Store at room temperature

  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, Sorbitol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Laureth-4, Fragrance, Menthol, Sodium Hydroxide, Polyquaternium-39, Disodium EDTA, Charcoal Powder, Sodium Benzoate, Benzyl Alcohol, Benzoic Acid, Sorbic Acid.

  • Questions?

    Call toll free 1-877-99-GENOM (43666) Monday to Friday, 8am to 6pm, Central time.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Genomma Lab USA Inc., Houston, TX, 77027.

  • PRINCIPAL DISPLAY PANEL - 224 mL Bottle Label

    NEW

    Asepxia®

    LIQUID ACNE CLEANSER

    PURIFY YOUR SKIN
    Removes impurities on skin surface

    With the power of
    Salicylic Acid.

    + ACTIVATED
    CHARCOAL

    Oil Free

    7.6 FL OZ
    (224 mL)

    2000008253

    PRINCIPAL DISPLAY PANEL - 224 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ASEPXIA LIQUID ACNE CLEANSER 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sorbitol (UNII: 506T60A25R)  
    Cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    Laureth-4 (UNII: 6HQ855798J)  
    Activated Charcoal (UNII: 2P3VWU3H10)  
    Product Characteristics
    ColorBLACKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-060-01224 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D09/25/2019
    Labeler - Genomma Lab USA (832323534)
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