Label: ONE STEP HAND SANITIZER ALOE- 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 September 11, 2013

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  • PRINCIPAL DISPLAY PANEL

    DRUG FACTS

    Active Ingredient

    Ethyl Alcohol 62%

    USE WHENEVER SOAP AND WATER ARE NOT AVAILABLE AND TO SUPPLEMENT ROUTING HAND WASHING

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

  • INDICATIONS & USAGE

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

  • WARNINGS

    FOR EXTERNAL USE ONLY, KEEP OUT OF REACH OF CHILDREN, FLAMMABLE, AVOID CONTACT WITH EYES SHOULD THIS OCCUR FLUSH 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 NO STORE ABOVE 40​0 ​C/110​0​F

  • DOSAGE & ADMINISTRATION

    APPLY LIBERALLY TO HAND AND RUB THOROUGHLY UNTIL DRY

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    

    IMAGE OF FRONT AND BACK LABEL 236ML
    IMAGE OF FRONT AND BACK LABEL 1L
    IMAGE OF FRONT AND BACK LABEL 60ML

    

  • INGREDIENTS AND APPEARANCE
    ONE STEP HAND SANITIZER ALOE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60742-001
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60742-001-01236 mL in 1 BOTTLE, PUMP
    2NDC:60742-001-0260 mL in 1 BOTTLE
    3NDC:60742-001-031000 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/31/2012
    Labeler - BELVEDERE INTERNATIONAL INC. (247836356)
    Registrant - BELVEDERE INTERNATIONAL INC. (247836356)
    Establishment
    NameAddressID/FEIBusiness Operations
    BELVEDERE INTERNATIONAL INC.247836356manufacture(60742-001)
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