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PAZOL (salicylic acid, sulfur, and coal tar) shampoo
[Stratus Pharamceuticals, Inc]


NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.

Drug Facts

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

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)

Principal Display Panel - 118 mL Bottle Label

INGREDIENTS & APPEARANCE

PAZOL   XS
salicylic acid, sulfur, and coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58980-890
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid20 mg  in 1 mL
Sulfur (Sulfur) Sulfur20 mg  in 1 mL
Coal Tar (Coal Tar) Coal Tar0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Lauryl Sulfate 
Cocamidopropyl Betaine 
Coco Diethanolamide 
Sodium Laureth Sulfate 
Water 
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-890-401 in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER07/01/2011
Labeler - Stratus Pharamceuticals, Inc (789001641)
Establishment
NameAddressID/FEIBusiness Operations
Sonar Products, Inc104283945MANUFACTURE

Revised: 6/2011
 
Stratus Pharamceuticals, Inc