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Pazol

Stratus Pharamceuticals, Inc

PAZOL ™XS MEDICATED SHAMPOO


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredient      Purpose
Coal Tar 1%       Scalp psorasis
                 (5% Coal Tar Solution)
Salicylic acid 2% Keratolytic
Sulfur 2% Dandruff

Pazol Uses

Helps stop recurrence of itchy flaky scalp associated with dandruff, seborrheic dermatitis and psorasis.

WARNINGS

  • For external use only.
  • Do not use on children under 2 years of age except under supervision of doctor.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • If condition worsens or does not improve after regular use of the product as directed, consult a doctor.
  • 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.
  • Do not use for prolonged periods without consulting a doctor.
  • Do not use this product with other forms of psorasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor. If condition covers a large area of the body, consult your doctor before using this product.
  • If swallowed, contact a poison control center right away.
  • Keep out of the reach of children.

DIRECTIONS

  • Always follow directions of your physician.
  • Shake well before use.
  • Apply generously, massage onto wet scalp.
  • Leave lather on scalp for five (5) minutes.
  • Rinse and repeat application followed by thorough rinse.
  • For best results use at least twice a week or as directed by a doctor.

OTHER INFORMATION

  • Itching and scaling are usually controlled after 2-3 treatments.
  • Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. Protect from freezing. If freezing occurs, warm to room temperature. For more information, see enclosed package insert.

Questions and Comments

1-800-442-7882

Inactive Ingredients

Acrylates, Aminoacrylates, C10-30 Alkyl PEG-20 Itaconate Co-Polymer, Cocamidopropyl Betaine, Cocamide DEA, Fragrance, Purified Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate and Soya Lecithin.

Distributed by:
STRATUS
PHARMACEUTICALS INC

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 58980-890-40

PAZOL ™
XS
MEDICATED
SHAMPOO

(Contains Sulfur,
Salicylic Acid
and Coal Tar)

Distributed by:
STRATUS
PHARMACEUTICALS INC

STRATUS PHARMACEUTICALS. INC
12379 SW 130th Street
Miami, Florida 33186

NET VOL.: 4.0 FL OZ (118 mL)

Pazol

Pazol

Salicylic Acid, Sulfur, and Coal Tar SHAMPOO

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58980-890
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Salicylic Acid SALICYLIC ACID 20 mg
SULFUR SULFUR 20 mg
COAL TAR Coal Tar 0.5 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM LAURYL SULFATE
COCAMIDOPROPYL BETAINE
Coco Diethanolamide
SODIUM LAURETH SULFATE
water

Product Characteristics

Color
YELLOW

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:58980-890-40 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-07-01


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