Label: XTRACARE INSTANT HAND SANITIZER COCOA BUTTER- alcohol liquid

  • Category: HUMAN OTC DRUG LABEL

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 Cocoa Butter


  • Active ingredient

    Ethyl Alcohol 62.0%

  • Purpose

    Antimicrobial

  • Uses

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

  • Directions

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • supervise children under 6 years in the use of this product 
  • Other information

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

    water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, titanium dioxide, cocoa seed butter.

  • XtraCare

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

  • PRINCIPAL DISPLAY PANEL

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

  • Product Labels

    Cocoa Butter 236 ml

  • INGREDIENTS AND APPEARANCE
    XTRACARE INSTANT HAND SANITIZER COCOA BUTTER  
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-003
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-003-081 in 1 PACKAGE
    1236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E02/08/2013
    Labeler - Rejoice International (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem528196956manufacture(57337-003)
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