Label: DERMABON PSORIASIS AND DANDRUFF- coal tar soap

  • NDC Code(s): 49758-100-10
  • Packager: Dermabon de Chihuahua, S. de R.L. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 5, 2020

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  • Dermabon Psoriasis and Dandruff Soap

    Drug Facts

  • Active Ingredients

    Coal Tar   2.13%

  • Purpose

    Anti-psoriasis, Anti-dandruff

  • Uses

    For the relief of dandruff and psoriasis

  • Warnings

    • For external use only.
    • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
    • If condition worsens or does not improve after regular use of this product as directed, consult a doctor.
    • Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.
    • Do not use for prolonged periods without consulting a doctor.
    • Do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.
    • If condition covers a large area of the body, consult your doctor before using this product.
  • Directions

    • Use on affected areas in place of your regular soap.
  • Inactive Ingredients

    Borax, Ethyl alcohol, Glycerin, Glyceryl Stearate, Lanolin, Metil Paraben, Sodium Hypochlorite, Stearic Acid , Petrolatum Oil, Vitamin E, Soap base and Water.

  • Inactive Ingredients

    KEEP OUT OF REACH OF CHILDREN

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    DERMABON PSORIASIS AND DANDRUFF 
    coal tar soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49758-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR2.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49758-100-1090 g in 1 PACKAGE; Type 0: Not a Combination Product10/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/01/2009
    Labeler - Dermabon de Chihuahua, S. de R.L. de C.V. (951580110)
    Registrant - Dermabon de Chihuahua, S. de R.L. de C.V. (951580110)