Label: XTRACARE INSTANT HAND SANITIZER COCOA BUTTER  - alcohol liquid 

  • 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

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  • XtraCare instant Hand Sanitizer Cocoa Butter
  • Active ingredient

    Ethyl Alcohol 62.0%

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  • Purpose

    Antimicrobial

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  • Uses

    • for handwashing to decrease bacteria on the skin
    • recommended for repeated use
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  • Warnings

    For external use only.
    Flammable, keep away from heat and flame.

    Do not use

    In the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    irritation and redness develop and persist for more than 72 hours.

    Keep out of reach of children.

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

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  • Directions

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • supervise children under 6 years in the use of this product 
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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, titanium dioxide, cocoa seed butter.

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  • XtraCare

    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 Cocoa Butter  kills 99.9% of Germs with Moisturizers and Cocoa Butter  8 fl. oz(236ml)

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  • Product Labels
  • INGREDIENTS AND APPEARANCE
    XTRACARE INSTANT HAND SANITIZER COCOA BUTTER  
    alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57337-003
    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  
    TITANIUM DIOXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57337-003-08 1 in 1 PACKAGE
    1 236 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(57337-003)
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