Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 6ad7f931-5411-474b-a86e-b511811b7dc0
Route
TOPICAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (3 g)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Peg-120 Methyl Glucose Dioleate Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Trolamine Panthenol .alpha.-tocopherol Acetate Tea Tree Oil Green Tea Leaf Ascorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-01

Description

Active ingredient Purpose Salicylic Acid 3% Psoriasis and  Seborrheic Dermatitis


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses 

Relieves and helps prevent recurrence of scalp:

  • irritation
  • itching
  • redness

  • flaking

  • scaling due to psoriasis and seborrheic dermatitis
Description

Active ingredient Purpose Salicylic Acid 3% Psoriasis and  Seborrheic Dermatitis

Section 50565-1

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

Section 55105-1
Active ingredient Purpose
Salicylic Acid 3% Psoriasis and 

Seborrheic Dermatitis
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)

When Using This Product
  • avoid contact with eyes
  • If contact occurs, rinse the eyes thoroughly with water
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
Stop Use and Ask A Doctor If
  • condition worsens or does not improve after regular use as directed

Structured Label Content

Indications and Usage (34067-9)

Uses 

Relieves and helps prevent recurrence of scalp:

  • irritation
  • itching
  • redness

  • flaking

  • scaling due to psoriasis and seborrheic dermatitis
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

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

Section 55105-1 (55105-1)
Active ingredient Purpose
Salicylic Acid 3% Psoriasis and 

Seborrheic Dermatitis
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 (Other information)
  • store between 20° – 25°C (68° – 77°F)
Inactive Ingredients (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? (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)

When Using This Product (When using this product)
  • avoid contact with eyes
  • If contact occurs, rinse the eyes thoroughly with water
Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or does not improve after regular use as directed

Advanced Ingredient Data


Raw Label Data

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