Label: 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 May 1, 2020

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  • DRUG FACTS

  • Purpose

    Antiseptic, Hand Sanitizer

  • USES:

    HELPS REDUCE BACTERIA ON THE SKIN.

    RECOMMENDED FOR REPEATED USE.

  • WARNINGS:

    FOR EXTERNAL USE ONLY. FLAMMABLE

    KEEP AWAY FROM FIRE OR FLAME.

  • WHEN USING

    WHEN USING THIS PRODUCT, AVOID

    CONTACT WITH EYES. IN CASE OF CON-

    TACT WITH EYES, FLUSH THOROUGHLY

    WITH WATER. AVOID CONTACT WITH

    BROKEN SKIN.

  • STOP USE

    STOP USE AND ASK DOCTOR IF IRRITA-

    TION OR REDNESS DEVELOPS, OR IF

    CONDITION PERSISTS FOR MORE THAN

    72 HOURS.

  • 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:

    DISPENSE ONE PUMP OF SANITIZER ON-

    TO HANDS AND RUB TOGETHER UNTIL

    DRY. USE AS NEEDED. FOR CHILDREN UN-

    DER 6, USE WITH ADULT SUPERVISION.

    NOT RECOMMENDED FOR INFANTS.

  • OTHER INFO:

    STORE BELOW 110 (DEGREES FAHREN-

    HEIT). MAY CAUSE DISCOLORATON TO

    CERTAIN FABRICS AND SURFACES

  • INACTIVE INGREDIENTS:


    DENATURED DEHYDRATED ALCOHOL
    40B, WATER, ALOE BARBADENSIS (AL-
    OE VERA) LEAF JUICE, GLYCERIN, PRO-

    PYLENE GLYCOL, CARBOMER, PRO-

    PANEDIOL, 2-AMINO METHYL-1 PROPA-

    NOL SOLUTION, TOCOPHERYL ACE-

    TATE (VITAMIN E ACETATE), HELIAN-

    THUS ANNUUS (SUNFLOWER) SEED OIL
    (AND) VACCINIUM MACROCARPON
    (CRANBERRY) FRUIT EXTRACT (AND)
    PUNICA GRANATUM EXTRACT (AND)
    VACCINIUM AN-GUSTIFOLIUM (BLUE-

    BERRY) EXTRACT (AND) FRAGARIA
    VESCA (STRAWBERRY) FRUIT EXTRACT
    (AND) ACTINIDIA CHINENSIS (KIWI) E,
    SIMMONDSIA CHINENSIS.

  • Package Label - Principal Display Panel

    236 mL NDC 21839-845-01 236 mL NDC 21839-845-01

    236 mL NDC 21839-845-02

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-845
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPANEDIOL (UNII: 5965N8W85T)  
    BLUEBERRY (UNII: 253RUG1X1A)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21839-845-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/13/2020
    2NDC:21839-845-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/13/2020
    Labeler - GORDON LABORATORIES,INC (008328619)
    Registrant - GORDON LABORATORIES,INC (008328619)
    Establishment
    NameAddressID/FEIBusiness Operations
    GORDON LABORATORIES,INC008328619manufacture(21839-845)
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