Label: BIOMAX USA ANTIBACTERIAL HAND WASH- benzalkonium chloride soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 1, 2020

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

  • Active ingredient:

    Benzalkonium chloride..........0.13%

  • Purpose

    Antibacterial

  • Other ingredients:..............99.78%

    Aqua/Water/Eau, Cocamidopropyl Betaine, PEG-150-distearate, Cocamide MEA, Aloe Barbadensis Leaf Juice ( Aloe Vera Leaf Juice), Glycerin, Parfum (Fragrance), Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium chloride, Magnesium Nitrate, Citric Acid, CI 19140 (FD&C Yellow No. 5), CI 42090 (FD&C Blue 1).

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use

  • Warnings

    FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. FOR USE WITH ADULT SUPERVISION. PRODUCT NOT TESTED ON ANIMALS.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply directly on hands, massage and rinse.

  • SPL UNCLASSIFIED SECTION

    HEALTHCARE

    aloe vera

    Refreshing deep cleanser

    NATURALLY CLEAN | SULFATE-FREE | PARABEN-FREE

    Wash away harmful bacteria with a light, clean, pleasant scent of Aloe Vera . This moisturizing hand wash with aloe vera oil washes dirt and bacteria for good hand hygiene. 

    Fragrance: The reviving scent of Aloe Vera provides an invigorating aromatherapy experience like no other.

    Manufactured by:

    Biomax Cosmetics Inc.

    Houston, TX 77061

    www.biomaxcosmetics.com

    MADE IN USA

  • Packaging

    IMAGE

    IMAGE

  • INGREDIENTS AND APPEARANCE
    BIOMAX USA ANTIBACTERIAL HAND WASH 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77369-955
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77369-955-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
    2NDC:77369-955-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/26/2020
    Labeler - Biomax Cosmetics (084032031)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biomax Cosmetics084032031manufacture(77369-955)