Label: ASEPXIA SOFTENING ACNE BAR- salicylic acid soap

  • 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 March 20, 2020

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  • Drug Facts

  • Active Ingredient

    Salicylic Acid, 2%

    Purpose

    Acne treatment

  • Uses

    • For the treatment of acne
    • Reduces the number of acne pimples
    • Allows skin to heal
    • Penetrates pores to clear most acne blemishes
    • Dries up acne pimples
    • Helps keep skin clear of new acne blemishes, acne pimples, whiteheads and blackheads
  • Warnings

    For external use only

    When using this product, skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a doctor. Avoid contact with eyes. If product gets in eyes, rinse 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

    • Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne.
    • 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

    Sodium palmate, Sodium cocoate and/or Sodium palm kernelate, Water, Glycerin, Fragrance, Sodium laureth sulfate, Sodium hydroxide, Sodium chloride, Glycereth-26, Tetrasodium etidronate, Glycolic acid, Mineral oil, Titanium dioxide, Cucumis sativus (Cucumber) fruit extract, Stearic Acid, Cetyl alcohol, Glyceryl stearate, Salix alba (White Willow) bark extract, FD&C Blue 1, Citric acid, Disodium EDTA, Triethanolamine, Opuntia Ficus-Indica (Cactus) stem extract, Carbomer, D&C Red 33, Iron Oxide, Pentasodium pentetate

  • QUESTIONS

    For more product information, please call Toll Free: 1 877 99 GENOM (43666)

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 113 g Bar Carton

    NEW
    FORMULA

    DRY SKIN WITH IMPERFECTIONS

    Asepxia®
    WITH HYDRO-FORCE®
    Acne Bar Soap

    Softening
    DEEP CLEANSING + MOISTURIZING

    2% Salicylic Ácid

    Enriched with cucumber extract

    > Cleans skin and leaves a soft & fresh feel

    > Wash away dirt, oil, bacteria and dead skin cells

    Net Wt. 4 oz (113 g)

    Principal Display Panel - 113 g Bar Carton
  • INGREDIENTS AND APPEARANCE
    ASEPXIA SOFTENING ACNE BAR 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CUCUMBER (UNII: YY7C30VXJT)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorImprint Code Asepxia
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-805-011 in 1 CARTON03/19/2020
    1113 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/19/2020
    Labeler - Genomma Lab USA (832323534)
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