Label: XTRACARE FOAMING HAND SANITIZER- benzalkonium chloride gel

  • 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

    Benzalkonium Chloride 0.13% .......... Antimicrobial

  • PURPOSE

    Use:

    to help reduce bacteria on the skin

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    XtraCare® Foaming Hand Sanitizer

    Superior Protection

    Alcohol Free

    Kills 99.9% of germs

    Clean Fresh Scent

    7 FL OZ (207 mL)

  • WARNINGS

    Warnings: for external use only.

    When using this product  Avoid contact with eyes. In case of eye contact, flush with plenty of water. Avoid contact with broken skin.

    Stop use and ask a doctor if skin iffitation develops.

  • DOSAGE & ADMINISTRATION

    Directions

    wet hands thoroughly with product and rub into skin until dry.

    For children under 6, use only under adult supervision.

    Not recommended for infancts.

  • INACTIVE INGREDIENT

    Inactive Ingredients: water, cetrimonium chloride, disodium cocoamphodiacetate, fragrance, glycerin, citric acid, dimethicone, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone.

  • OTHER SAFETY INFORMATION

    Questions/Comments? 1-855-345-5575

    DISTRIBUTED BY:

    REJOICE INTERNATIONAL INC

    NORTHVILLE, MI 48168 USA

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    XTRACARE FOAMING HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-057
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE3 g  in 207 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-057-01207 g in 1 PACKAGE; Type 0: Not a Combination Product02/18/2014
    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(58503-057)
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