Label: HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E- 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 2, 2014

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  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Use

     ■ Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable. Keep away from fire or flame

  • When using this product

    do not use in or near ther eyes. In case of contact rinse eyes thoroughly with water.

    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

  • Stop use and ask a doctor

    if irritation or rash appears and lasts.

  • Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    ■ Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry ■ Children under 6 years of age should be supervised when using this product

  • Other information

    ■ Store below 106F (41C) ■ May discolor certain fabrics or surfaces.

  • Inactive ingredients

    water, glycerin, propylene glycol, carbomer, isopropyl alcohol, peg-40 hydrogenated castor oil, aminomethyl propanol, isopropyl myristate, caprylyl glycol, phenoxyethanol, fragrance, tocopheryl acetate.

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  WITH MOISTURIZERS AND VITAMIN E
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46994-503
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46994-503-08236 mL in 1 BOTTLE, PUMP
    2NDC:46994-503-0259 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/25/2013
    Labeler - Save-A-Lot Food Stores Ltd (095484572)
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