Label: GERMFREE HAND SANITIZER BABYPOWDER FRAGRANCE- ethanol 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 March 27, 2020

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  • ACTIVE INGREDIENT

    Alcohol (Ethanol)

  • INACTIVE INGREDIENT

    Glycerin, Triethanolamine, Carbomer, Fragrance, Water

  • PURPOSE

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    do not use in or near the eyes. If contact occurs, rinse thoroughly with water.
    avoid contact with broken skin.

  • WARNINGS

    For external use only.
    Flammable, keep away from heat and 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.

  • DOSAGE & ADMINISTRATION

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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GERMFREE HAND SANITIZER BABYPOWDER FRAGRANCE 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70812-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70812-002-0175 mL in 1 TUBE; Type 0: Not a Combination Product03/26/2020
    2NDC:70812-002-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/26/2020
    Labeler - BIOSTECH CO., LTD. (687294330)
    Registrant - BIOSTECH CO., LTD. (687294330)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIOSTECH CO., LTD.687294330label(70812-002) , pack(70812-002) , manufacture(70812-002)