Label: XTRACARE INSTANT HAND SANITIZER ORIGINAL- alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 28, 2013

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  • XtraCare instant Hand Sanitizer Original


  • Active ingredient:

    Ethyl Alcohol 62.0%

  • Purpose

    Antimicrobial

  • USE:

    • hand sanitizer to help reduce bacteria on the skin that may cause disease.
  • Warnings:

    for external use only.
    Flammable. Keep away from heat and flame.

    When using this product

    • avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.

    Stop use and ask a doctor if

    • irritation or redness develops.

    Keep out of reach of children.

    if swallowed, get medical help or contact a Poison Control Center.

  • Directions

    • wet hands thoroughly with product and rub into skin until dry.
    • children under 6 years of age should be supervised by an adult when using.
  • Other Information:

    • store at 200C to 250C (680 to 770F)
    • may discolor certain fabrics.
  • Inactive ingredients:

    water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, tocopheryl acetate (Vitamin E).

  • XtraCare

    Hook it to your backpack, key chain, sports bag, purse, or anywhere you want the hand sanitizer!

    DISTRIBUTED BY: REJOICE INTERNATIONAL INC. 48325 BINGHAMPTON DR, NOTRHVILLE, MI 48168, USA
    MADE IN CHINA.

  • PRINCIPAL DISPLAY PANEL

    XtraCare instant Hand Sanitizer Original Kills 99.9% of Germs Instantly  2PK 2 X 1.8 FL OZ (53 ml) TOTAL 3.6 FL OZ (106 mL)

  • Product Labels

    Original 53 mlOriginal 2 Pack

  • INGREDIENTS AND APPEARANCE
    XTRACARE INSTANT HAND SANITIZER ORIGINAL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-000
    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 ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-000-022 in 1 PACKAGE
    1NDC:57337-000-0053 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E02/07/2013
    Labeler - Rejoice International (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem528196956manufacture(57337-000)
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