Label: XTRACARE INSTANT HAND SANITIZER ORIGINAL - alcohol liquid 

  • NDC Code(s): 57337-000-00, 57337-000-02
  • Packager: Rejoice International
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • XtraCare instant Hand Sanitizer Original
  • Active ingredient:

    Ethyl Alcohol 62.0%

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  • Purpose

    Antimicrobial

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  • USE:

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

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  • 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.
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  • Other Information:

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

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

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  • 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.

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  • 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)

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  • Product Labels
  • INGREDIENTS AND APPEARANCE
    XTRACARE INSTANT HAND SANITIZER ORIGINAL 
    alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57337-000
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    TROLAMINE  
    GLYCERIN  
    PROPYLENE GLYCOL  
    .ALPHA.-TOCOPHEROL ACETATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57337-000-02 2 in 1 PACKAGE
    1 NDC:57337-000-00 53 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333E 02/07/2013
    Labeler - Rejoice International (078741245)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Unichem 528196956 manufacture(57337-000)
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