Label: HEALTHCARE INSTANT HAND SANITIZER VANILLA SCENT- alcohol liquid

  • 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 August 10, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient:

    Ethyl Alcohol 62.0%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE


    USE:

    • for handwashing to decrease bacteria on the skin
    • recommended for repeated use
  • WARNINGS

    Warnings: for external use only.

    Flammable. Keep away from heat and flame.

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION


    Directions

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • supervise children in the use of this product
  • STORAGE AND HANDLING

    Other information

    • store at 20 degrees C to 25 degrees C (68 degrees to 77 degrees F)
    • may discolor certain fabrics
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Aloe Vera Leaf Juice, Carbomer, FD C Red No.33, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate ( Vitamin E), Triethanolamine, Water.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    GREAT LAKES WHOLESALE

    AND MARKETING L.L.C

    GRAND RAPIDS, MICHIGAN 49512

    www.glwholesale.com

    Made in China

  • PRINCIPAL DISPLAY PANEL

    HEALTH

    CARE

    INSTANT HAND SANITIZER

    Kills 99.9% of Germs without water or towels!

    Vanilla Scent

    Extra Enriched With Vitamin E Bead And Aloe

    8 fl oz (237 ml)

    Vanilla

  • INGREDIENTS AND APPEARANCE
    HEALTHCARE INSTANT HAND SANITIZER VANILLA SCENT 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-108
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-108-08237 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/10/2011
    Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem Household Products Co., Ltd.528196956manufacture
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