Label: PSORMEDICOR PREMIUM SKIN CARE PRODUCT- coal tar ointment

  • 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 November 11, 2013

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  • Active Ingredient:

    Coal Tar (2.5%)



  • Purpose:

    Psoriasis/Sebhorreic Dermatitis Treatment


  • Uses:

    For the relief of symptoms associated with psoriasis and or seborrheic dermatitis including itching, scaling, flaking, redness and irritation of the skin. Helps prevent recurrences. Treats eczema.


  • Warnings:

    For external use only. Will stain clothing. Avoid exposure to sun during treatment and for the following 24 hours.


    Ask a doctor before use.

    For prolonged periods. If condition covers a large area of the body around the rectum or in the genital area or groin with other forms of psoriasis therapy such as ultraviolet radiation or prescription.


  • Directions:

    • Read all package directions and warnings before using.
    • Use as directed.
    • Apply (gently massage in) a small amount of PsorMedicor to affected areas.
    • Apply on clean skin or after a shower.
    • Wait for 10 minutes to allow for ventilation, cover with single-use cloth.
    • Leave on for at least 3 hours or during a night.
    • Wash skin after treatment.
    • Use for 7-14 days.
    • Intended for use by normally healthy adults only.
    • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
  • Questions or Comments?

    Call (865) Psorsis, 855-776-7747 Monday through Friday.


  • Inactive Ingredients:

    Water, Petrolatum, Cocoa Butter, PEG - 1500, Olive Oil, Lanolin, Stearic Acid, Glycerol Monostearate, Triethanolamine, Methocel, Thymol, Dihydroacetic acid Na Salt, Dimethylurea.


  • Principal Display Panel

    PsorMedicor

    PREMIUM SKIN CARE

    PRODUCT

    Unique Formula

    Relieves:

    • Psoriasis
    • Sebhorreic Dermatitis
    • Itching
    • Flaking
    • More Powerful
    • Faster  Acting

    Does not contain Cortisone or Steroids!

    PATENT PENDING

    50 ml - 1.7 oz

    unttitlted.jpg

  • INGREDIENTS AND APPEARANCE
    PSORMEDICOR  PREMIUM SKIN CARE PRODUCT
    coal tar ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54095-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    LANOLIN (UNII: 7EV65EAW6H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    THYMOL (UNII: 3J50XA376E)  
    1,3-DIMETHYLUREA (UNII: WAM6DR9I4X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54095-111-1050 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H11/11/2013
    Labeler - Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD (533464103)
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