Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 3f8bc77e-a5cf-469c-9733-22d3de33ef5a
Route
TOPICAL
Published
Effective Date 2023-09-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (3 g)
Inactive Ingredients
Allantoin Arachidyl Alcohol Arachidyl Glucoside Yellow Wax Benzyl Alcohol Shea Butter Cetostearyl Alcohol Chlorphenesin Cyclomethicone 5 Dimethicone Disodium Edta-copper Edetate Disodium Anhydrous Glyceryl Stearate Citrate Hydrogenated Polydecene Type I Isododecane Isosorbide Dicaprylate Laureth-4 Laureth-23 Panthenol Peg-100 Stearate Peg-7 Trimethylolpropane Coconut Ether Propylene Glycol Sodium Hydroxide .alpha.-tocopherol Acetate Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Active ingredient Purpose Salicylic Acid 3.0% Psoriasis


Medication Information

Warnings and Precautions

Warnings

For external use only

Description

Active ingredient Purpose Salicylic Acid 3.0% Psoriasis

Uses
  • for the relief of itching, scaling, redness, flaking, and irritation associated with psoriasis
  • helps prevent recurrence of psoriasis symptoms
Section 50565-1

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 53413-1

Questions? 1-800-824-4894

Section 55105-1
Active ingredient Purpose
Salicylic Acid 3.0% Psoriasis
Directions
  • apply to affected areas one to four times daily or as directed by a doctor

Other Information
  • store product at 20-25°C (68-77°F)
  • keep carton for full product information.
Inactive Ingredients

allantoin, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, benzyl alcohol, butyrospermum parkii(shea) butter, cetearyl alcohol, chlorphenesin, cyclopentasiloxane, dimethicone, disodium EDTA, ethylhexyl isononanoate, glyceryl stearate, hydrogenated polydecene, isododecane, isosorbide dicaprylate, laureth-4, laureth-23, panthenol, PEG-100 stearate, PEG-7 trimethylolpropane coconut ether, propylene glycol, sodium hydroxide, tocopheryl acetate, water, xanthan gum

Principal Display Panel

NEW



Nizoral®




Psoriasis

Relief Cream

SALICYLIC ACID 3%



For Psoriasis Affected Skin



RELIEVES


Itching, Irritation & Redness



CONTROLS

Flaking & Scaling



HELPS PREVENT

Recurrence of

Psoriasis Symptoms



FAST-ACTING

Starts Working from First Use



Free of Fragrance, Steroids,

Dyes & Parabens



Net wt 4 oz (113 g)



Specially

formulated

with:

√  Shea Butter

√  Vitamin B5

√  Vitamin E



Free of:

  Steroids

  Fragrances

Ⅹ  Dyes

  Parabens



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



© 2023 KRAMER

LABORATORIES, INC.



K0723

When Using This Product
  • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
Ask A Doctor Before Use If
  • condition covers a large area of the body
Stop Use and Ask Doctor If
  • condition worsens or does not improve after regular use of this product as directed


Structured Label Content

Uses
  • for the relief of itching, scaling, redness, flaking, and irritation associated with psoriasis
  • helps prevent recurrence of psoriasis symptoms
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 53413-1 (53413-1)

Questions? 1-800-824-4894

Section 55105-1 (55105-1)
Active ingredient Purpose
Salicylic Acid 3.0% Psoriasis
Directions
  • apply to affected areas one to four times daily or as directed by a doctor

Other Information (Other information)
  • store product at 20-25°C (68-77°F)
  • keep carton for full product information.
Inactive Ingredients (Inactive ingredients)

allantoin, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, benzyl alcohol, butyrospermum parkii(shea) butter, cetearyl alcohol, chlorphenesin, cyclopentasiloxane, dimethicone, disodium EDTA, ethylhexyl isononanoate, glyceryl stearate, hydrogenated polydecene, isododecane, isosorbide dicaprylate, laureth-4, laureth-23, panthenol, PEG-100 stearate, PEG-7 trimethylolpropane coconut ether, propylene glycol, sodium hydroxide, tocopheryl acetate, water, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW



Nizoral®




Psoriasis

Relief Cream

SALICYLIC ACID 3%



For Psoriasis Affected Skin



RELIEVES


Itching, Irritation & Redness



CONTROLS

Flaking & Scaling



HELPS PREVENT

Recurrence of

Psoriasis Symptoms



FAST-ACTING

Starts Working from First Use



Free of Fragrance, Steroids,

Dyes & Parabens



Net wt 4 oz (113 g)



Specially

formulated

with:

√  Shea Butter

√  Vitamin B5

√  Vitamin E



Free of:

  Steroids

  Fragrances

Ⅹ  Dyes

  Parabens



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



© 2023 KRAMER

LABORATORIES, INC.



K0723

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)