Label: HAND SANITIZER 70 PERCENT- 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 May 23, 2020

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 70% V/V

  • PURPOSE

    ANTIMICROBIAL

  • USES

    HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    FLAMMABLE, KEEP AWAY FROM OPEN FIRE OR FLAME.

    WHEN USING THIS PRODUCT DO NOT USE NEAR THE EYES. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

    STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH AND LASTS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS BRISKLY TOGETHER UNTIL DRY.
    • CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.
    • NOT RECOMMENDED FOR INFANTS.

  • OTHER INFORMATION

    • STORE BELOW 110°F (43°C)
    • MAY DISCOLOR CERTAIN FABRICS OR SURFACE.
  • INACTIVE INGREDIENTS

    WATER, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, ETHYLHEXYLGLYCERIN, PANTHENOL (PRO-VITAMIN B5), FRAGRANCE.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_sani-X gel_front

    01b LBL_sani-X gel_DF Box

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  70 PERCENT
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-104
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43219-104-022 mL in 1 POUCH; Type 0: Not a Combination Product05/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/06/2020
    Labeler - Emilia Cosmetics Ltd (600076624)
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