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Psoriasin by Alva-Amco Pharmacal Companies, Inc.

Dosage form: gel
Ingredients: Coal tar 12.5mg in 1g
Labeler: Alva-Amco Pharmacal Companies, Inc.
NDC Code: 52389-266

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.

Active ingredient

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

Purpose

Psoriasis/Seborrheic Dermatitis Treatment

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 
coal tar gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-266
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Coal tar (Coal tar) Coal tar12.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aloe vera leaf 
alcohol 
Hydroxypropyl cellulose 
Isopropyl alcohol 
Polyethylene glycol 400 
Polysorbate 80 
Water 
ALPHA-TOCOPHEROL ACETATE 
LANOLIN 
Packaging
#Item CodePackage Description
1NDC:52389-266-281 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H02/18/1996
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

 
Alva-Amco Pharmacal Companies, Inc.

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Medically reviewed on May 22, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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