Label: XTRACARE INSTANT HAND SANITIZER - alcohol spray

  • NDC Code(s): 57337-001-00, 57337-001-02
  • 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 Spray
  • Active ingredient

    Ethyl Alcohol 62%

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  • Purpose

    Antimicrobial

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  • Uses

    • hand sanitizer to help reduce bacteria on the skin that may cause disease.
    • recommended for repeated use
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  • Warnings

    Flammable. Keep away from fire or flame.
    For external use only

    When using this product


    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin.

    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.

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  • Directions

    • spray enough product in your palm to thoroughly cover your hands
    • rub hands together briskly until dry
    • children under 6 years of age should be supervised when using this product
    • not recommended for infants
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  • Other Information

    • store below 1050F (400C)
    • may discolor certain fabrics or surfaces
    • harmful to wood finishes and plastics
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  • Inactive ingredients

    Water, Glycerin, Fragrance, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, FDandC Blue No. 1, FDandC Yellow No. 5.

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  • XtraCare

    instant Hand Sanitizer Spray  Kills 99.9% of Germs Instantly

    • Use anywhere without the need for water
    • 100+sprays per bottle

    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 Spray 2 PK 100+SPRAYS  Kills 99.9% of Germs Instantly  Leaves hands feeling soft with Aloe and Vitamin E  Convenient Size for Purse, Pocket or Car  PERFECT FOR TRAVEL  2x0.34 fl oz(2x10 ml)

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  • Product Labels
  • INGREDIENTS AND APPEARANCE
    XTRACARE INSTANT HAND SANITIZER 
    alcohol spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57337-001
    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  
    GLYCERIN  
    ALOE VERA LEAF  
    .ALPHA.-TOCOPHEROL ACETATE  
    FD&C BLUE NO. 1  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57337-001-02 2 in 1 PACKAGE
    1 NDC:57337-001-00 10 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333E 02/08/2013
    Labeler - Rejoice International (078741245)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Unichem 528196956 manufacture(57337-001)
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