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Psorent

NeoStrata Company Inc.

Psorent™


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Coal Tar 2.3% (from Coal Tar Topical Solution, USP 15%)

Purpose

Psoriasis Treatment

Psorent Uses

Helps eliminate and prevent recurrence of these symptoms due to psoriasis:

  • skin irritation
  • itching
  • flaking
  • redness
  • scaling

Warnings

For external use only.

Ask a doctor before use

  • for prolonged periods
  • if condition covers a large area of the body
  • in or around the rectum or in the genital area or groin
  • with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs
  • on children under 2 years of age
  • if you are pregnant or breastfeeding

When using this product

  • avoid contact with 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.

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

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Flammable. Keep away from heat or flame.

Directions

  • Read all package directions and warnings before use.
  • Use only as directed.
  • Apply to affected areas one to two times daily or as directed by a doctor.
  • Dab gently onto affected skin to start the flow of medication. Application pad may already be wet upon initial opening.
  • Apply just enough medication to wet the skin and avoid dripping.
  • Avoid applying to severely cracked or irritated areas.
  • Allow solution to fully dry before dressing to avoid staining clothing.
  • Do not rinse off treated skin.
  • Cap bottle tightly after use.

Other Information

Store upright at 15° - 30° C (59° - 86° F). Keep away from extreme heat, cold, and direct sunlight. Do not bring on an airplane, as leakage may occur in luggage.

Warning

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

Inactive Ingredients

Cyclomethicone, Dioctyldodecyl Dodecanedioate, Ethyl Alcohol, Fragrance, Polyoxyethylene (2) Oleyl Ether, Propylene Glycol, Triethyl Citrate

PRINCIPAL DISPLAY PANEL - 100 ml Bottle Carton

NeoStrata ®
therapeutics

PSORENT
psoriasis
topical solution

Treatment and
Management

3.4 fl oz /100 ml

Psorent

Psorent

COAL TAR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58414-8960
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
COAL TAR Coal Tar 23 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
CYCLOMETHICONE 5
OLETH-2
DIOCTYLDODECYL DODECANEDIOATE
propylene glycol
TRIETHYL CITRATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE, WITH APPLICATOR
2 NDC:58414-8960-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partH part358H 2013-07-17


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Be sure to consult your doctor before taking any medication!
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