Label: BATURALS HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 April 7, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 75%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use ▪ Helps decrease bacteria on skin. ▪ Recommended for repeated use.

  • WARNINGS

    Warnings Flammable. Keep away from fire or flame. For external use only

    When using this product do not use in or near the eyes.

    In case of contact, rinse eyes thoroughly with water.

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

    Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions ▪ Place enough product in your palm to thoroughly cover your hands

    ▪ Rub hands together briskly until dry

    ▪ Children under 6 years of age use only under adult supervisions

  • STORAGE AND HANDLING

    Other information ▪ Store at 77°F (25°C) ▪ May discolor fabrics

  • Inactive ingredients

    Water, Propylene, Glycerin, Fragrance, Carbomer, Triethanolamine, Tocopheryl Acetate

  • SPL UNCLASSIFIED SECTION

    Kills 99.9% of Germs

    Refreshing Gel

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    BATURALS HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74218-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE (UNII: AUG1H506LY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74218-001-5050 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/07/2020
    Labeler - Guangdong Authenmole Biotech Inc. (559966091)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Authenmole Biotech Inc.559966091manufacture(74218-001)
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