Label: ASEPXIA ACNE TREATMENT- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicilic Acid 2%

  • Purpose

    Acne Treatment

  • Uses

    • for the treatment of acne
    • dries and clears acne blemishes
    • penetrates pores to eliminate most acne blemishes
    • helps prevent new acne blemishes
  • Warnings

    For external use only

    When using this product

    • skin irritation and dryness is more likely to occur if you use another acne medication at the same time. If irritation occurs, use only one topical acne med cation at a time

    Keep out of reach of children

    • if swallowed, get medical help or contact a Poison Control Center right away
  • 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
    • If irritation or sensitivity develops, stop use and ask a doctor

    Sensitivity test for new user

    • apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above
  • Other information

    • Keep tightly closed
    • Store at room temperature
  • Inactive ingredients

    Acrylamide Sodium Acrylate Copolymer, Cyclopentasiloxane, Ethylhexylglycerin, Glycerin, Paraffinum Liquid, Phenoxyethanol, Polysorbate 20, Propylene glycol, Sodium Citrate, Trideceth-6, Water.

  • Questions or comments?

    1 877 994 3666. Monday to Friday, 8am to 6pm, Central time.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Genomma Lab USA Inc., Houston, TX 77098

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Asepxia®

    ACNE TREATMENT CREAM

    2 % SALICYLIC ACID

    ELIMINATES MOST PIMPLES AND BLACKHEADS

    NET WT.
    1 OZ (28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ASEPXIA ACNE TREATMENT 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-064
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-064-011 in 1 CARTON09/05/2024
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/05/2024
    Labeler - Genomma Lab USA (832323534)
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