Label: ONE STEP HAND SANITIZER- 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 January 27, 2012

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62%

    USE WHENEVER SOAP AND WATER ARE NOT AVAILABLE AND TO SUPPLEMENT ROUTINE HAND WASHING APPLY LIBERALLY TO HAND AND RUB THOROUGHLY UNTIL DRY

    CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT, KEEP OUT OF REACH OF CHILDREN

    ONE STEP 473mL

    USE WHENEVER SOAP AND WATER ARE NOT AVAILABLE AND TO SUPPLEMENT ROUTINE HAND WASHING APPLY LIBERALLY TO HAND AND RUB THOROUGHLY UNTIL DRY



    FOR EXTERNAL USE ONLY, KEEP OUT OF REACH OF CHILDREN, FLAMMABLE, AVOID CONTACT WITH EYES SHOULD THIS OCCUR FLUSH EYES WITH WATER DISCONTINUE USE IF IRRITATION DEVELOPS IF CONDITION PERSISTS FOR MORE THAN 72 HOURS CONSULT YOUR PHYSICIAN. IF SWALLOWED CONTACT A PHYSICIAN AS WELL. DO NOT STORE ABOVE 40 0 C/110 0F

    USE WHENEVER SOAP AND WATER ARE NOT AVAILABLE AND TO SUPPLEMENT ROUTINE HAND WASHING APPLY LIBERALLY TO HAND AND RUB THOROUGHLY UNTIL DRY

  • INACTIVE INGREDIENT

    WATER, ISOPROPYL ALCOHOL, CARBOMER, ALOE VERA LEAF, POLYSORBATE 20

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF PRODUCT LABELONE STEP 473mL.jpg

  • INGREDIENTS AND APPEARANCE
    ONE STEP HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60742-473
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 934 (UNII: Z135WT9208)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60742-473-01473 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/27/2012
    Labeler - Belvedere International Inc. (247836356)
    Establishment
    NameAddressID/FEIBusiness Operations
    Belvedere International Inc.247836356manufacture