Label: ONE STEP HAND SANITIZER ALOE- alcohol gel 

  • Label RSS
  • NDC Code(s): 60742-001-01, 60742-001-02, 60742-001-03
  • Packager: BELVEDERE INTERNATIONAL INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

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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

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  • 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

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  • 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

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  • DOSAGE & ADMINISTRATION

    APPLY LIBERALLY TO HAND AND RUB THOROUGHLY UNTIL DRY

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  • INACTIVE INGREDIENT

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

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  • PRINCIPAL DISPLAY PANEL

    

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

    

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  • INGREDIENTS AND APPEARANCE
    ONE STEP HAND SANITIZER ALOE 
    alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:60742-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    POLYSORBATE 20  
    ALOE VERA LEAF  
    CARBOMER 934  
    ISOPROPYL ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60742-001-01 236 mL in 1 BOTTLE, PUMP
    2 NDC:60742-001-02 60 mL in 1 BOTTLE
    3 NDC:60742-001-03 1000 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 01/31/2012
    Labeler - BELVEDERE INTERNATIONAL INC. (247836356)
    Registrant - BELVEDERE INTERNATIONAL INC. (247836356)
    Establishment
    Name Address ID/FEI Business Operations
    BELVEDERE INTERNATIONAL INC. 247836356 manufacture(60742-001)
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