Label: ANTISEPATION ANTIMICROBIAL CLEANSING GEL- benzethonium chloride gel

  • NDC Code(s): 61619-717-12, 61619-717-14, 61619-717-18
  • Packager: A-Cute Derm, Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

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

  • DRUG FACTS

    • Kills 99.9% of harmful germs in 30 seconds
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  • Active Ingredient

    Benzethonium Chloride (0.20%)

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  • Purpose

    Antimicrobial

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  • Inactive Ingredients

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

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  • Uses

    Antisepation® 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.

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  • Warnings

    •External use only. •Do not use in eyes. •In case of deep wounds or puncture wounds, consult a physician. •If irritation develops and persists for more than a few days, discontinue use and consult a physician.

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  • KEEP OUT OF REACH OF CHILDREN

    • ​Keep out of reach of children
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  • 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.

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  • Other Information

    • Alcohol Free
    • Moisturizes
    • Made In USA

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  • Questions or Comments

    A-Cute Derm Inc.
    1810 Cravens Road
    Stafford, Texas 77477-3534
    Phone: 800.922.2883
    Internet: www.a-cutederm.com
    Email: info@a-cutederm.com
    Hours: M-F 8:30pm-5:30pm

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  • Images of Antisepation Labels for 4.0 FL.OZ. and 32 FL. OZ.

    AntisepationGel4ozLabel.jpgBottle Label AntisepationGel32ozLabel.jpgRefill Label

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  • INGREDIENTS AND APPEARANCE
    ANTISEPATION  ANTIMICROBIAL CLEANSING GEL
    benzethonium chloride gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61619-717
    Route of Administration CUTANEOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE 2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    AMMONIUM LAURYL SULFATE  
    LAURAMIDOPROPYL BETAINE  
    HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE  
    PROPYLENE GLYCOL  
    HYPROMELLOSES  
    SODIUM CHLORIDE  
    DIAZOLIDINYL UREA  
    PEG-4 LAURATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    IODOPROPYNYL BUTYLCARBAMATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61619-717-14 118.294 mL in 1 BOTTLE, PLASTIC
    2 NDC:61619-717-18 236.588 mL in 1 BOTTLE, PLASTIC
    3 NDC:61619-717-12 946.353 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 03/13/2014
    Labeler - A-Cute Derm, Incorporated (809845803)
    Establishment
    Name Address ID/FEI Business Operations
    Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(61619-717)
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