Label: XTRACARE INSTANT HAND SANITIZER- ethyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 13, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient                                Purpose

    Ethyl Alcohol 62.0% ...................... Antimicrobial

  • PURPOSE

    Uses

    for handwashing to decrease bacteria on the skin

    recommended for repeated use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    XtraCare® Instant Hand Sanitizer

    Kills 99.9% Of Germs

    Moisturizes with Vitamin E

    2 FL OZ (60 mL)

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

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

    Inactive Ingredients

    water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, tocopheryl acetate.

  • OTHER SAFETY INFORMATION

    Other Information

    • store at 20oC to 25oC (68o to 77oF)
    • may discolor certain fabrics

    Questions/Comments? 1-855-345-5575

    DISTRIBUTED BY

    REJOICE INTERNATIONAL INC

    NORTHVILLE, MI 48168 USA

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    label image

    box image

  • INGREDIENTS AND APPEARANCE
    XTRACARE INSTANT HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-058
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL37 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-058-022 in 1 PACKAGE02/18/2014
    1NDC:58503-058-0160 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/18/2014
    Labeler - China Ningbo Shangge Cosmetic Technology Corp (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(58503-058)
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