NIZORAL PSORIASIS- salicylic acid shampoo

Nizoral Psoriasis by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Salicylic Acid 3%

Purpose

Psoriasis and Seborreic Dermatitis

Uses

Relieves and helps prevent recurrence of scalp:

irritation

itching

redness

flaking

scaling due to psoriasis and seborreic 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 eyes thoroughly with water

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

SPL UNCLASSIFIED SECTION

label

label

INGREDIENTS AND APPEARANCE

NIZORAL PSORIASIS 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44038-0202
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
TEA TREE OIL (UNII: VIF565UC2G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44038-0202-1	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 - Accupac LLC (071609663)

Registrant - Accupac LLC (061595175)