NIZORAL PSORIASIS- salicylic acid shampoo

Nizoral Psoriasis by

Drug Labeling and Warnings

Nizoral Psoriasis by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories, Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient: Purpose
• Salicylic Acid 3%: Psoriasis and ; Seborrheic Dermatitis

INDICATIONS & USAGE

Uses 
Relieves and helps prevent recurrence of scalp:

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

WARNINGS

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

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

Ascorbic Acid, Cocamidopropyl Betaine, DL Panthenol USP Powder, Green Tea Extract, Linolemidopropyl PG-Dimonium Chloride Phosphate, PEG-120 Methyl Glucose Dioleate, Polyquaternium-7, Propylene Glycol, Puried Water, Sodium C-14-16 Olefin Sulfonate, Tea Tree Oil, Trolamine, Vitamin E Acetate

Questions or comments?

Call 800-824-4894

Principal Display Panel

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

© 2022 KRAMER
LABORATORIES, INC.

K1222

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)

INGREDIENTS AND APPEARANCE

NIZORAL PSORIASIS 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-202-64	1 in 1 CARTON	12/01/2020
1		325 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	12/01/2020

Labeler - Kramer Laboratories (122720675)