Label: BIOMAX USA HAND SANITIZER- ethyl alcohol liquid

  • 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 July 27, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Inactive Ingredient

    Water(Aqua), SDA Alcohol, Triethanolamine, Carbomer, Aloe Barbadensis, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E), CI 42090, CI 19140.

  • Uses:

    For hand washing to help reduce bacteria on the skin.

  • Directions

    • Put a small amount in your palm and rub hands together until dry.

    • Children under 6 years of age should be supervised when using this product. Recommended for repeated use.

  • Warnings

    For external use only-hands.

    Flammable. Keep away from heat and flame.

    Stop use and ask a doctor if irritation or redness develops and lasts.

    When using this product

    • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

    If Swallowed, get medical help or contact a Poison Control Center immediately.

  • SPL UNCLASSIFIED SECTION

    ADVANCED Hand Sanitizer

    MOISTURIZING WITH VITAMIN E & ALOE

    KILLS 99.99% OF MOST GERMS

    MADE IN USA

    Manufactured by:

    Biomax Cosmetics Inc.

    Houston, TX 77061

    www.biomaxcosmetics.com

    BENEFITS:

    • With Vitamin E.

    • Leaves hands feeling soft & refreshed.

    • Kills more than 99.99% of germs and bacteria.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    BIOMAX USA HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77369-927
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE (UNII: V5VD430YW9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77369-927-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    2NDC:77369-927-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    3NDC:77369-927-08236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    4NDC:77369-927-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    5NDC:77369-927-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    6NDC:77369-927-013785 mL in 1 JUG; Type 0: Not a Combination Product07/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/08/2020
    Labeler - Biomax Cosmetics (084032031)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biomax Cosmetics084032031manufacture(77369-927)
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