Label: BIOFRESH HAND SANITIZER- alcohol gel

  • 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 19, 2020

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  • Drug Facts

  • Active Ingredient :

    Alcohol IP (Denatured) eq. to absolute alcohol 70% v/v

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    ​Uses: • For handwashing to decrease bacteria on the skin • recommended for repeated use

  • Warnings

    For external use only.

    Flammable, Keep away from heat or flame.

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help

  • DOSAGE & ADMINISTRATION

    ​Directions • wet hands thoroughly with product • briskly rub hands together until dry • supervise children under 6 years in the use of this product

  • INACTIVE INGREDIENT

    Ingredients: Alcohol IP (Denatured) 70% v/v, Glycerin, Propylene Glycol, Tea Tree Extract, Aloevera Extract, Triethanolamine, Color, Purified Water

  • SPL UNCLASSIFIED SECTION

    Kills 99.99% of Germs

    Protects Hands

    Refreshing & Protection Gel

    With Moisturizer Neem Extract & Vitamins E & A

    Manufactured by :

    HINDUSTAN HERBAL COSMETICS

    Visit us : www.biofreshherbals.com

    Made In India​

  • Packaging

    BIOFRS1IMAGE

  • INGREDIENTS AND APPEARANCE
    BIOFRESH HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77104-999
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77104-999-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2020
    2NDC:77104-999-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2020
    3NDC:77104-999-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2020
    4NDC:77104-999-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2020
    5NDC:77104-999-0530 mL in 1 BOTTLE; Type 0: Not a Combination Product08/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/10/2020
    Labeler - HINDUSTAN HERBAL COSMETICS (860308144)
    Establishment
    NameAddressID/FEIBusiness Operations
    HINDUSTAN HERBAL COSMETICS860308144manufacture(77104-999)
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