Label: INSTANT HAND SANITIZER- hand sanitizer kit

  • 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 November 1, 2009

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  • SPL UNCLASSIFIED SECTION

    Drug Facts
  • Active Ingredients


    Ethyl Alcohol  62%
  • Purpose


    Antiseptic

  • Warnings

    For external use only

    • flammable, keep away from fire and flame
    • will produce serious gastric disturbances if taken internally

    Ask a doctor before use if you have deep puncture wounds or serious burns

    When using this product

    • do not get into eyes or mucous membranes
    • use only in a well-ventilated area

    Stop use and ask a doctor if condition persists or gets worse.

    Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

  • Uses

    hand sanitizer to help decrease bacteria on the skin. when water, soap and towel are not available. recommended for repeated use
  • Warnings

    • For external use only
    • Flammable
    • Keep away from fire or flame

    Do not apply around eyes. Do not use in ears and mouth.

    When using this product, avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

    Keep out of reach of children. Children must be supervised in use of this product.

  • Directions

    pump as needed into your palms and thoroughly spread on both hands. rub skin until dry.

  • Other information

    store at 20 degree celsius (68 degrees to 77 degrees fahrenheit). may discolor fabrics.

  • Inactive ingredients

    water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, aloe barbadensis gel, carbomer, fragrance

  • Package Label

    Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    hand sanitizer kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:18018-501
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:18018-501-341 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 POUCH 1000 mL
    Part 21 BOTTLE, PUMP 237 mL
    Part 1 of 2
    INSTANT HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Item Code (Source)NDC:18018-501
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11000 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33311/01/2009
    Part 2 of 2
    INSTANT HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Item Code (Source)NDC:18018-501
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1237 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33311/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33311/01/2009
    Labeler - NINGBO CLEANER DAILY USED PRODUCTS CO. LTD. (527983808)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO CLEANER DAILY USED PRODUCTS CO. LTD.527983808manufacture
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