PSORIATAR (COAL TAR)- coal tar aerosol, foam 
Nivagen Pharmaceuticals, Inc.

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.

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Psoriatar (Coal Tar) Foam, 2% coal tar foam

Drug Facts

Active Ingredient

Coal Tar 2% (from Coal Tar Topical Solution USP, 10%)

Purpose

Psoriasis

Use

for the relief of symptons 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 large areas of the 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 breast feeding, 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

Other Information

Inactive Ingredients

Alcohol denatured, caprylic/capric triglyceride, ceteareth-20, cyclopentasiloxane, dimethicone, disodium edta, glycerin, hydroxypropyl methylcellulose, isobutane, isopropyl myristate, mentha piperita (peppermint) oil, phenoxyethanol, polysorbate 80, potassium sorbate, propane, sodium chloride, sodium citrate, stearic acid, water (aqua), xantham gum

Questions?

1-877-977-0687

PRINCIPAL DISPLAY PANEL - 100 g Can Label

75834-101-01
PSORIASIS FOAM

Psoriatar

(Coal Tar) Foam 2%

NIVAGEN
PHARMACEUTICALS

Net wt. 3.5 oz (100 g)

PRINCIPAL DISPLAY PANEL - 100 g Can Label
PSORIATAR (COAL TAR) 
coal tar aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75834-101
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
Isopropyl Alcohol (UNII: ND2M416302)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Edetate Disodium (UNII: 7FLD91C86K)  
Glycerin (UNII: PDC6A3C0OX)  
Hypromelloses (UNII: 3NXW29V3WO)  
Isobutane (UNII: BXR49TP611)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Peppermint Oil (UNII: AV092KU4JH)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Propane (UNII: T75W9911L6)  
Sodium Chloride (UNII: 451W47IQ8X)  
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75834-101-011 in 1 CARTON05/15/2016
1100 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H05/15/2016
Labeler - Nivagen Pharmaceuticals, Inc. (052032418)

Revised: 5/2016
Document Id: 140f2f13-0223-4de4-a779-02a4bc91afe0
Set id: bce479c0-6695-4580-9a87-1df69007cea4
Version: 1
Effective Time: 20160505
 
Nivagen Pharmaceuticals, Inc.