Label: A-CUTE DERM B-KLEER- benzethonium chloride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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  • DRUG FACTS

    A-Cute Derm B-Kleer Antimicrobial Cleansing Gel

  • Active Ingredients

    Benzethonium Chloride (0.2%)

  • Purpose

    Antimicrobial

  • Uses

    B-KLEER™ is a unique, non-drying cleanser. •Designed for all skin types and pH balanced. •Excellent for postoperative care. •May be used as a topical antimicrobial to help protect against skin infection.

  • Warnings

    For external use only.
    Do not use in eyes.
    Ask a doctor before use if you have deep wounds or puncture wounds.
    Stop use and ask a doctor if irritation develops.

    Keep out of reach of children.

  • Directions

    •Wet hands and other areas to be treated. •Place a small amount of gel in your hands and work into lather. •Apply lather to areas to be treated using a gentle, circular motion. •Rinse clean.

  • Other Information

    •Alcohol Free •Moisturizes •Made in USA

  • Inactive Ingredients

    Purified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Hydroxypropyl Bis-Hydroxyethyl-dimonium Chloride, Propylene Glycol, Hydroxypropylmethylcellulose, Sodium Chloride, Diazolidinyl Urea, PEG-4 Laurate, Methylparaben, Propylparaben, 3-iodo-2-propynylbutylcarbamate.

  • Questions or Comments

    Distributed. by ABBE Laboratories, Inc.
    1095 Route 110 Farmingdale, NY 11735
    1-800-457-0990

  • Principal Display Panel

    A-Cute Derm

    medical skincare

    B-Kleer TM

    Antimicrobial Cleansing Gel

    4.0 FL OZ (118.29 ml)antimicrobial

  • INGREDIENTS AND APPEARANCE
    A-CUTE DERM B-KLEER 
    benzethonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68605-1040(NDC:25280-005)
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE (UNII: 1EO3O1X7HG)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68605-1040-4118.29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2022
    2NDC:68605-1040-2946.35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2022
    3NDC:68605-1040-8236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00405/01/2022
    Labeler - ABBE Laboratories, Inc. (781745286)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABBE Laboratories, Inc.781745286repack(68605-1040)
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