Psoriatar™

Psoriatar™
SPL v1
SPL
SPL Set ID bce479c0-6695-4580-9a87-1df69007cea4
Route
TOPICAL
Published
Effective Date 2016-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Coal Tar (20 mg)
Inactive Ingredients
Isopropyl Alcohol Medium-chain Triglycerides Polyoxyl 20 Cetostearyl Ether Cyclomethicone 5 Dimethicone Edetate Disodium Glycerin Hypromelloses Isobutane Isopropyl Myristate Peppermint Oil Phenoxyethanol Polysorbate 80 Potassium Sorbate Propane Sodium Chloride Sodium Citrate, Unspecified Form Stearic Acid Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-05-15

Description

Drug Facts

Purpose

Psoriasis


Medication Information

Purpose

Psoriasis

Description

Drug Facts

Use

for the relief of symptons of psoriasis

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask doctor if condition worsens or does not improve after regular use of this product as directed.

Section 50567-7

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.
Section 50568-5

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.

Section 50569-3

Ask a doctor before use if you have a condition that covers large areas of the body.

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Warnings

For external use only

Flammable

Avoid fire, flame, or smoking during and immediately following application.

Directions
  • Shake the can 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.
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
Questions?

1-877-977-0687

Active Ingredient

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

Other Information
  • Contents under pressure. Do not puncture or incinerate.
  • Store at 68°-77°F (20°-25°C).
  • Do not expose to heat or at temperatures above 120°F (49°C).
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

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)


Structured Label Content

Use

for the relief of symptons of psoriasis

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask doctor if condition worsens or does not improve after regular use of this product as directed.

Section 50567-7 (50567-7)

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.
Section 50568-5 (50568-5)

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.

Section 50569-3 (50569-3)

Ask a doctor before use if you have a condition that covers large areas of the body.

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Purpose

Psoriasis

Warnings

For external use only

Flammable

Avoid fire, flame, or smoking during and immediately following application.

Directions
  • Shake the can 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.
Do Not Use (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
Questions?

1-877-977-0687

Active Ingredient

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

Other Information
  • Contents under pressure. Do not puncture or incinerate.
  • Store at 68°-77°F (20°-25°C).
  • Do not expose to heat or at temperatures above 120°F (49°C).
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

Principal Display Panel 100 G Can Label (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)


Advanced Ingredient Data


Raw Label Data

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