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Psoriasin

Alva-Amco Pharmacal Companies, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Coal tar 1.25% (from coal tar topical solution, USP)

Purpose

Psoriasis/Seborrheic Dermatitis Treatment

Psoriasin 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 recurrence.

Warnings

For external use only.

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 drugs.

When using this product avoid contact with the eyes.  If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

  • condition worsens
  • condition does not improve after regular use of this product as directed.

Use caution in exposing skin to sunlight after applying this product, as it may increase your tendency to sunburn for up to 24 hours after application.

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

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

Directions

  • Read all package directions and warnings before using.
  • Use only as directed.
  • Apply (gently massage in) a small amount of Psoriasin Gel to affected areas.
  • Apply one to four times daily or as directed by a doctor.
  • Apply to thoroughly dry skin.
  • The active ingredient, coal tar, in Psoriasin Gel may affect very light hair color; test first on a few strands of hair before broader application to areas where light colored hair is present.
  • Wash affected area at least daily with mild soap and warm water and dry thoroughly.
  • 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.

Other Information

You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Aloe vera gel, ethanol, hydroxypropyl cellulose, isopropyl alcohol, lanolin, polyethylene glycol, polysorbate 80, purified water and vitamin E acetate.

Questions?  1-800-792-2582

Psoriasin

Psoriasin

Coal Tar GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52389-266
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
COAL TAR Coal Tar 12.5 mg

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
ALCOHOL
hydroxypropyl cellulose
ISOPROPYL ALCOHOL
polyethylene glycol 400
polysorbate 80
water
ALPHA-TOCOPHEROL ACETATE
LANOLIN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28 in 1 TUBE
2 NDC:52389-266-28 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partH part358H 1996-02-18


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