Label: SCYTERA (COAL TAR) FOAM, 2%- coal tar foam, 2% aerosol, foam

  • 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 18, 2009

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  • DESCRIPTION

    Scytera™ Foam is an emollient foam containing 10% coal tar topical solution (Liquor Carbonis Detergens) equivalent to 2% coal tar.
  • Active Ingredient - Purpose

    Active ingredient: Coal Tar 2% (from Coal Tar Topical Solution USP, 10%)
    Purpose: Psoriasis
  • Use

    For relief of the symptoms of psoriasis.
  • Warnings

    For external use only.

    Flammable
    Avoid fire, flame, or smoking during and immediately following application.
  • Do not use

    • for prolonged periods without consulting a doctor
    • this product in or around the rectum or in the genital area or groin except on the advice of a doctor
  • Ask a doctor before use if you have

    a condition that covers a large area of your body.
  • Ask a doctor or pharmacist before use if you are

    using the product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs.
  • When using this product

    • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
    • 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.
    • product can stain clothing, contact lenses, and hair. To minimize staining, allow product to dry before contact.
  • Stop use and ask doctor if

    condition worsens or does not improve after regular use of this product as directed.
  • If pregnant or breastfeeding

    ask a health professional before use.
  • Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center right away.
  • Directions

    • shake the can well before use.
    • invert the can to dispense. Upright dispensing will cause loss of propellant.
    • apply to affected areas one to four times daily or as directed by a doctor.
  • Other information

    • contents under pressure. Do not puncture or incinerate.
    • store at 68°F to 77°F (20°C to 25°C)
    • do not expose to heat or store at temperatures above 120°F (49°C)
  • Inactive Ingredients

    Caprylic/capric triglyceride, ceteareth 20, citric acid, cyclomethicone, dimethicone, EDTA disodium, glycerin, hydroxypropyl methyl cellulose, isopropyl myristate, peppermint oil, phenoxyethanol, potassium sorbate, purified water, sodium citrate, stearic acid, xanthan gum, hydrocarbon (propane/butane) propellant. 
  • Questions?

    1-888-966-8766
  • WARNINGS

    Warning
    This product contains chemicals known to the state of California to cause cancer.


    Patent Pending
    Made in USA.
    Marketed by:
    Promius Pharma, LLC
    Bridgewater, NJ 08807
    Under license from
    Foamix LTD, Israel
  • Scytera™ (Coal Tar)Foam 2%, 100 g

    Carton and Can Label
    NDC 67857-801-52
    Psoriasis Foam

    Scytera™
    (Coal Tar) Foam 2%

    Promius Pharma    ™
    NET WT. 3.3 oz (100 g)
    Scytera_Carton_100_01
    Scytera_Can_100_01


    Carton (California)
    NDC 67857-801-26
    Psoriasis Foam

    Scytera™
    (Coal Tar) Foam 2%

    Promius Pharma    ™
    NET WT. 3.3 oz (100 g)
    Scytera_CA_Carton_100_01



  • Scytera™ (Coal Tar)Foam 2%, 12 g Sample Size

    Packer (Box)
    Available in 100 g Cans

    Scytera™
    (Coal Tar) Foam 2%
    Promius Pharma™

    Professional Samples

    Net Quantity 12 x 12 g Cans
    NDC 67857-801-12
    Scytera_Carton_12_01


    Packer (Box) (California)
    Available in 100 g Cans

    Scytera™
    (Coal Tar) Foam 2%
    Promius Pharma™

    Professional Samples

    Net Quantity 12 x 12 g Cans
    NDC 67857-801-19
    Scytera_CA_Carton_12_01


    Can Label

    NDC 67857-801-12
    Psoriasis Foam

    Scytera™
    (Coal Tar) Foam 2%

    SAMPLE, NOT FOR SALE
    NET WT. 0.4 oz (12 g)
    Scytera_Can_12_01

  • INGREDIENTS AND APPEARANCE
    SCYTERA  (COAL TAR) FOAM, 2%
    coal tar foam, 2% aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63094-0801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63094-0801-11 in 1 CARTON
    1100 g in 1 CAN
    2NDC:63094-0801-212 in 1 BOX
    212 g in 1 CAN
    3NDC:63094-0801-31 in 1 CARTON
    3NDC:63094-0801-1100 g in 1 CAN
    4NDC:63094-0801-412 in 1 BOX
    4NDC:63094-0801-212 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35810/31/2008
    Labeler - DPT Laboratories, Ltd. (621782218)
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