Label: ANTISEPATION- benzethonium chloride lotion

  • NDC Code(s): 61619-717-07, 61619-717-14, 61619-717-18, 61619-717-28, view more
    61619-717-32
  • 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 01/16

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

  • DRUG FACTS

    Kills 99.9% of harmful germs in 30 seconds.

    Close
  • Active Ingredients

    Benzethonium Chloride (0.2%)

    Close
  • Purpose

    Antimicrobial

    Close
  • Uses

    •AntisepationTM 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.

    Close
  • 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.

    Close
  • 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.

    Close
  • 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.

    Close
  • Other Information

    •Alcohol Free •Moisturizes •Made in USA

    Close
  • Questions or Comments

    A-Cute Derm, Inc.

    1810 Cravens Road

    Stafford, TX 77477

    800.922.2883

    M-F 8:30am-5:30pm

    info@a-cutederm.com

    www.a-cutederm.com

    Close
  • Principal Display Panel

    ANTISEPATIONTM

    CLEANSING GEL

    Kills 99.9% of Harmful

    Germs In 30 Seconds

    NDC# 61619-717-14

    4.0 FL OZ (118.3 ml Antiseption 4 fl. oz.

    Close
  • INGREDIENTS AND APPEARANCE
    ANTISEPATION 
    benzethonium chloride lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61619-717
    Route of Administration CUTANEOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61619-717-14 118.294 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2016
    2 NDC:61619-717-32 946.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2016
    3 NDC:61619-717-07 29.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2016
    4 NDC:61619-717-28 3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2016
    5 NDC:61619-717-18 236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 02/05/2016
    Labeler - A-Cute Derm, Incorporated (809845803)
    Establishment
    Name Address ID/FEI Business Operations
    Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(61619-717)
    Close