Label: JOHN DEERE INSTANT HAND SANITIZER- 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 December 19, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients

    Ethyl alcohol 60 - 65 %

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • Hand sanitizer to decrease bacteria on the skin
    • Recommended for repeated use
  • WARNINGS

    Warnings

    For external use only

    Flammable, keep away from fire or flame

    When using this product do not use in or near eyes. If in eyes, flush with water

    for 15 minutes.

    Stop use and ask a doctor if irritation or redness occurs and persists.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a

    Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions  - Apply a small amount in your palm and rub hands together

    until dry (about 15 seconds)   -Pay attention to areas around nails and fingers

  • STORAGE AND HANDLING

    Other information    Store below 37.8 C (100 F)

  • INACTIVE INGREDIENT

    Inactive ingredients   Water, propylene glycol, carbomer, glycerine,

    triethanolamine, fragrance, tocopheryl acetate, retinyl palmitate

  • QUESTIONS

    Questions?   Call John Deere: 1 800-822-8262

  • DESCRIPTION

    Kills 99.99% of harmful germs in as little

    as 15 seconds without soap and water

    • 60% certified corn ethanol
    • Non-irritating
    • CHG and latex compatible
    • Moisturizing formula with vitamins A and E
  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    JOHN DEERE INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70190-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL600 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70190-100-016 in 1 CARTON11/01/2015
    1251 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/01/2015
    Labeler - TIG Distributing, Inc. (616213968)
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