Label: GREAT VALUE ORANGE SCENT- orange chloroxylenol soap

  • 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 March 7, 2017

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  • ACTIVE INGREDIENT

    Active ingredient

    Chloroxylenol 0.30%

    Use helps fight germs on hands when used as a hand soap

    For external use only

    Keep out of reach of children. In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.

    Directions wet hands and forearms. Apply 5 mL or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse.

    Dishwashing Liquid and Antibacterial hand soap

    Inactive ingredients Water, Sodium Laureth Sulfate, Sodium Dodecylbenzenesulfonate, Sodium Chloride, Alcohol Denat., Sodium Xylenesulfonate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Benzisothiazolinone, Methylisothiazolinone, Methylchloroisothiazolinone, Fragrance, FD&C Yellow No. 5, D&C Red No. 33

    Questions? 1-877-505-2267

  • PRINCIPAL DISPLAY PANEL

    LBLFR LBLBKLBLFR

    LBLBK

    RBWM490009531_490009532MECH LBL FR LBL BK-page-001.jpg

  • INGREDIENTS AND APPEARANCE
    GREAT VALUE ORANGE SCENT 
    orange chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63691-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63691-033-10709 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2016
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/01/2016
    Labeler - Sun Products Corporation (070931480)
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