Label: ASEPXIA OIL-FREE 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

If you are a consumer or patient please visit this version.

  • 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, Sodium chloride, Sulfur, Fragrance, Sodium hydroxide, Tetrasodium EDTA, Pentasodium pentetate, Glycolic acid, Titanium dioxide, Salix alba (White Willow) bark extract, BHT, FD&C Yellow 5, Citric Acid, Disodium EDTA, Opuntia Ficus-Indica (Cactus) stem extract, FD&C Yellow 6, Iron Oxide

  • 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

    OILY SKIN WITH IMPERFECTIONS

    Asepxia ®
    WITH HYDRO-FORCE™

    Acne Bar Soap

    Oil-Free
    DEEP CLEANSING ANTI-SEBUM

    2% Salicylic Acid
    Enriched with a touch of sulfur*

    > Oil skin control

    > Deeply cleans and exfoliates without overdrying

    Net Wt. 4 oz (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Bar Carton
  • INGREDIENTS AND APPEARANCE
    ASEPXIA OIL-FREE ACNE BAR 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-803
    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
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SULFUR (UNII: 70FD1KFU70)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code Asepxia
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-803-011 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)