Label: CLEAN HANDS CARE HAND SANITIZER GEL- 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 April 24, 2020

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  • ACTIVE INGREDIENT

    ethanol

  • PURPOSE

    ■ sterilization of hands and skin

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • WARNINGS

    ■ Flammable. Keep away from fire or flame.

    ■ For external use only.

    ■ Do not use in eyes.

    ■ lf swallowed, get medical help promptly.

    ■ Stop use, ask doctor lf irritation occurs.

    ■ Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    for external use only

  • INACTIVE INGREDIENT

    aloe vera gel, glycerin, CARBOMER, Mentha Oil, Scutellaria Baicalensis Root Extract, grapefruit seed extract,

    purified water

  • INDICATIONS & USAGE

    wet hands thoroughly with product and allow to dry without wiping

    for children under 6, use only under adult supervision

    not recommended for infants

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    CLEAN HANDS CARE HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72139-0003
    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
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72139-0003-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2020
    Labeler - SANDULBADA LIFE PHARM (694191773)
    Registrant - SANDULBADA LIFE PHARM (694191773)
    Establishment
    NameAddressID/FEIBusiness Operations
    SANDULBADA LIFE PHARM694191773manufacture(72139-0003)
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