NIZORAL PSORIASIS- salicylic acid shampoo 
Kramer Laboratories

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.

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Drug Facts

Active ingredientPurpose
Salicylic Acid 3%Psoriasis and 
Seborrheic Dermatitis

Uses 
Relieves and helps prevent recurrence of scalp:

  • irritation
  • itching
  • redness
  • flaking
  • scaling due to psoriasis and seborrheic dermatitis

Warnings
For external use only

Ask a doctor before use if

  • you have psoriasis that covers a large area of the body
  • if you are allergic to ingredients in this product

When using this product

  • avoid contact with eyes
  • If contact occurs, rinse the eyes thoroughly with water

Stop use and ask a doctor if

  • condition worsens or does not improve after regular use as directed

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • for best results use at least twice a week or as directed by a doctor
  • wet hair thoroughly
  • massage liberal amount of product into scalp
  • leave lather on for several minutes
  • rinse thoroughly and repeat if needed

Other information

  • store between 20° – 25°C (68° – 77°F)

Inactive ingredients

Purified Water, Sodium C-14-16 Olefin Sulfonate, Cocamidopropyl Betaine, PEG-120 Methyl Glucose Dioleate, Polyquaternium-7, Trolamine, Phospholipid EFA, DL Panthenol USP Powder, Vitamin E Acetate, Tea Tree Oil, Green Tea Extract, Ascorbic Acid

Questions or comments?

Call 800-824-4894

Principal Display Panel

NEW

Nizoral®

Psoriasis

SALICYLIC ACID 3%
SHAMPOO & CONDITIONER


Scalp Psoriasis Shampoo & Conditioner
with Tea Tree Oil

CONTROLS
Redness, Flaking and Scaling

RELIEVES
Itching and Scalp Irritation

FAST-ACTING
Starts Working from First Use

Sulfate, Dye and Alcohol-Free

11 fl oz (325mL)

Specially formulated with:
✓ Tea Tree Oil
✓  Green Tea
✓  Vitamin E
✓  Vitamin B5
✓  Vitamin C

Free of:
X  Sulfates
X  Dyes
X  Alcohol
X  Artificial Fragrances
X  Preservatives
X  Parabens

What is Scalp Psoriasis?
Scalp psoriasis is a chronic inflammatory condition that comes and goes. Symptoms may include irritation, itching, redness, and flaking.

How does Nizoral Psoriasis Shampoo & Conditioner work?
Nizoral contains maximum strength medicine to relieve and help prevent scalp psoriasis symptoms while leaving hair clean and conditioned. The special formula contains tea tree oil, green tea and vitamins E, C and B5 - plus it's free of artificial fragrances, preservatives, and dyes that may irritate skin.

Read all information on this packaging and keep for future reference.

Before use, read all label information. If you have a drug reaction, contact a doctor and report it by calling: 1.800.824.4894

Distributed by:
Kramer Laboratories, Inc.
Bridgewater, NJ 08807
USA

© 2020 KRAMER LABORATORIES, INC.

K0620

carton

Nizoral®
Psoriasis

SALICYLIC ACID 3%  SHAMPOO & CONDITIONER

Scalp Psoriasis Shampoo & Conditioner
with Tea Tree Oil

CONTROLS
Redness, Flaking and Scaling

RELIEVES
Itching and Scalp Irritation

FAST-ACTING
Starts Working from First Use

Sulfate, Dye and Alcohol-Free

11 fl oz (325mL)

front label

back label
NIZORAL PSORIASIS 
salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Peg-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)  
Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw) (UNII: 0L414VCS5Y)  
Trolamine (UNII: 9O3K93S3TK)  
Panthenol (UNII: WV9CM0O67Z)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Tea Tree Oil (UNII: VIF565UC2G)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Ascorbic Acid (UNII: PQ6CK8PD0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55505-202-641 in 1 CARTON12/01/2020
1325 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/01/2020
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(55505-202)

Revised: 11/2020
 
Kramer Laboratories