Label: SOFTCIDE- chloroxylenol soap

  • NDC Code(s): 55863-155-51, 55863-155-62, 55863-155-65, 55863-155-70
  • Packager: Erie Scientific LLC
  • 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 August 24, 2023

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  • ACTIVE INGREDIENT

    CHLOROXYLENOL............1%

  • PURPOSE

    ANTICEPTIVE AGENT

  • INDICATIONS & USAGE

    Handwash to help reduce bacteria that can potentially cause disease. Reduces the risk and chance of cross -infection.

  • WARNINGS

    For external use only.

    If swallowed seek medical help or contact poison control immediately

    Avoid contact with eyes. If contact occurs flush with water

    Discontinue use and contact a health practitioner if irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Wet skin and apply a sufficient amount on hands and forearms

    Scrub well and rinse thoroughly after washing

  • INACTIVE INGREDIENT

    OLIVE OIL
    WALNUT OIL
    JOJOBA OIL
    RICE BRAN OIL
    GAMOLENIC ACID
    ALKYL (C12-15) BENZOATE
    QUATERNIUM-15
    EDETATE SODIUM
    CITRIC ACID MONOHYDRATE
    ALOE VERA LEAF
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%)
    ALLANTOIN
    COCAMIDOPROPYL BETAINE
    SODIUM LAURETH SULFATE
    COCAMIDOPROPYL HYDROXYSULTAINE
    POLYSORBATE 20
    PEG-150 DISTEARATE
    SODIUM LAUROYL SARCOSINATE

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SOFTCIDE 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55863-155
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.001 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    WALNUT OIL (UNII: Y0P3555R51)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    GAMOLENIC ACID (UNII: 78YC2MAX4O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    ALLANTOIN (UNII: 344S277G0Z)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55863-155-51118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2017
    2NDC:55863-155-62473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2017
    3NDC:55863-155-65800 mL in 1 BAG; Type 0: Not a Combination Product04/10/2017
    4NDC:55863-155-70946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/10/2017
    Labeler - Erie Scientific LLC (361605223)
    Establishment
    NameAddressID/FEIBusiness Operations
    KUTOL PRODUCTS COMPANY004236139manufacture(55863-155)
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