Label: SOFTCIDE-ES 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 July 23, 2013

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  • ACTIVE INGREDIENT

    Chloroxylenol 0.3% w/w

  • INACTIVE INGREDIENT

    Water, Tall Oil Acid, Potassium Hydroxide, Sodium Lauryl Sulfate, Coconut Acid, Cocamide DIPA, Phenoxyethanol, Tetrasodium EDTA, Sodium Sulfate, Sodium Laureth Sulfate, Aloe Barbadensis Leaf, Tocopheryl Acetate (Vitamin E Acetate), Iodopropynyl Butylcarbamate, Fragrance, Red 33, Yellow 5

  • DOSAGE & ADMINISTRATION

    Wet skin and apply a sufficient amount on hands and forearms. Scrub well and rinse thoroughly after washing.

  • PURPOSE

    Handwash to help reduce bacteria that can potentially cause disease.

  • INDICATIONS & USAGE

    Handwash to help reduce bacteria that can potentially cause disease.

    Avoid contact with the eyes. If contact occurs, flush eyes with water.

    Discontinue use and consult a health practitioner if irritation develops. If swallowed seek medical help or contact Posion Control immediately. Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

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

  • WARNINGS

    Avoid contact with eyes. If contact occurs, flush eyes with water.

    For external use only.

    Avoid contact with the eyes. If contact occurs, flush eyes with water.

    Discontinue use and consult a health practitioner if irritation develops.

    If swallowed seek medical help or contact Posion Control immediately.

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    55863-281-27-ERI.jpg55863-281-27-ERI.jpg

  • PRINCIPAL DISPLAY PANEL

    55863-281-32-ERI.jpg55863-281-32-ERI.jpg

  • PRINCIPAL DISPLAY PANEL

    55863-281-32-VWR.jpg55863-281-32-VWR.jpg

  • PRINCIPAL DISPLAY PANEL

    55863-281-27-VWR.jpg55863-281-27-VWR.jpg

  • INGREDIENTS AND APPEARANCE
    SOFTCIDE-ES 
    softcide-es liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55863-281
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL12.604 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    TALL OIL (UNII: 1GX6Z36A79)  
    COCONUT ACID (UNII: 40U37V505D)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55863-281-27800 mL in 1 BAG
    2NDC:55863-281-32946 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/13/2013
    Labeler - Erie Scientific, LLC (361605223)
    Registrant - Kutol Products Company, Inc. (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company, Inc.004236139manufacture(55863-281) , pack(55863-281) , analysis(55863-281)
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