Label: ANTIBACTERIAL SOAP- chloroxylenol 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 May 10, 2010

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  • DOSAGE & ADMINISTRATION

    Directions:

    Wet hands and forearms. Apply a small amount (approx. 5 ml) to hands and scrub thoroughly. Rinse well and dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water (aqua) sodium laureth sulfate, cocamidopropyl betaine, decyl glucoside, Cocamide DEA, sodium chloride, glycerin, fragrance, citric acid, DMDM hydantoin, Yellow 5, Red 4

  • INDICATIONS & USAGE

    Use:

    For handwashing to decrease bacteria on the skin.

  • ACTIVE INGREDIENT

    Active Ingredient                  Purpose

    Chloroxylenol 0.5%               Antiseptic

  • WARNINGS

    Warnings:

    For external use only.

    Keep out of reach of children.

    Avoid eye contact. Should contact occur, rinse thoroughly with water.

    If swallowed or irritation develops, discontinue use and consult a health care practitioner.

  • PRINCIPAL DISPLAY PANEL


    label

    Antibacterial gel Soap

    Chloroxylenol 0.5%

    800 ml (27 US fl oz)

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL SOAP 
    chloroxylenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51053-502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q) chloroxylenol4 mL  in 800 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51053-502-081 in 1 BOX
    1800 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2010
    Labeler - Sanihealth Products Corporation (244200478)
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