Denorex Severe Itch

Denorex Severe Itch
SPL v1
SPL
SPL Set ID 213ccbc4-2f52-58b6-e063-6294a90ae248
Route
TOPICAL
Published
Effective Date 2025-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Coal Tar (0.018 g)
Inactive Ingredients
Triethanolamine Sulfate Peg/ppg-4/12 Dimethicone Coco Diethanolamide Alcohol Avocado Oil Chloroxylenol Citric Acid Monohydrate Fd&c Red No. 40 Glycol Distearate Hypromelloses Panthenol Ricinoleamidopropyl Ethyldimonium Ethosulfate .alpha.-tocopherol Acetate Water Sunflower Oil Peg-30 Lanolin Trolamine Polysorbate 80 Propylene Glycol Quaternium-80 Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-13

Description

Drug Facts

Purpose

Anti-itch, anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis


Medication Information

Purpose

Anti-itch, anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Description

Drug Facts

Uses

Reduces and helps prevent recurrence of these symptoms of dandruff:

  • scalp irritation and itching • flaking • scaling • extra relief of itching due to dandruff
Section 42229-5

Drug Facts

Section 51945-4

ADVANCED RELIEF



Denorex®

SEVERE ITCH

MEDICATED

ANTI-DANDRUFF

SHAMPOO + CONDITIONER



1.8 % Coal Tar / DANDRUFF,

SEBORRHEIC DERMATITIS + PSORIASIS



INSTANT SOOTHING RELIEF



CONTROLS & RELIEVES:

SEVERE ITCHING

SCALP DISCOMFORT

INFLAMMATION

FLAKING & SCALING

associated with dandruff, seborrheic dermatitis + psoriasis

1.8% COAL TAR



10 FL OZ (296 mL)

Warning

This product can expose you to chemicals including coal tar, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

Warnings

For external use only

Directions
  • for best results, use at least twice a week or as directed by a doctor
  • shake well before use
  • apply to wet hair
  • massage into scalp, leave lather on for several minutes
  • rinse thoroughly and repeat for maximum relief
Questions?

Call 1-888-398-1382

email [email protected] or visit www.denorex.com

Other Information

Store at 68-77°F (20-25°C)

Active Ingredients

Coal Tar 1.8%

(from Coal Tar Topical Solution, USP 20%)

Inactive Ingredients

Aqua/Water/Eau, TEA Lauryl Sulfate, Alcohol, Cocamide DEA, PEG-30 Lanolin, Glycol Distearate, Fragrance/Parfum, Menthol, Panthenol, Persea Gratissima (Avocado) Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Triethanolamine, PEG/PPG-4/12 Dimethicone, Hydroxypropyl Methylcellulose, Chloroxylenol, Polysorbate 80, Propylene Glycol, Quaternium 80, Ricinoleamidopropyl Ethyldimonium Ethosulfate, Citric Acid, Red 40

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water

Stop Use and Ask A Doctor

if condition worsens or does not improve after regular use of this product as directed.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

a condition covers a large area of the body.


Structured Label Content

Uses

Reduces and helps prevent recurrence of these symptoms of dandruff:

  • scalp irritation and itching • flaking • scaling • extra relief of itching due to dandruff
Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

ADVANCED RELIEF



Denorex®

SEVERE ITCH

MEDICATED

ANTI-DANDRUFF

SHAMPOO + CONDITIONER



1.8 % Coal Tar / DANDRUFF,

SEBORRHEIC DERMATITIS + PSORIASIS



INSTANT SOOTHING RELIEF



CONTROLS & RELIEVES:

SEVERE ITCHING

SCALP DISCOMFORT

INFLAMMATION

FLAKING & SCALING

associated with dandruff, seborrheic dermatitis + psoriasis

1.8% COAL TAR



10 FL OZ (296 mL)

Purpose

Anti-itch, anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Warning (WARNING)

This product can expose you to chemicals including coal tar, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

Warnings

For external use only

Directions
  • for best results, use at least twice a week or as directed by a doctor
  • shake well before use
  • apply to wet hair
  • massage into scalp, leave lather on for several minutes
  • rinse thoroughly and repeat for maximum relief
Questions?

Call 1-888-398-1382

email [email protected] or visit www.denorex.com

Other Information (Other information)

Store at 68-77°F (20-25°C)

Active Ingredients

Coal Tar 1.8%

(from Coal Tar Topical Solution, USP 20%)

Inactive Ingredients (Inactive ingredients)

Aqua/Water/Eau, TEA Lauryl Sulfate, Alcohol, Cocamide DEA, PEG-30 Lanolin, Glycol Distearate, Fragrance/Parfum, Menthol, Panthenol, Persea Gratissima (Avocado) Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Triethanolamine, PEG/PPG-4/12 Dimethicone, Hydroxypropyl Methylcellulose, Chloroxylenol, Polysorbate 80, Propylene Glycol, Quaternium 80, Ricinoleamidopropyl Ethyldimonium Ethosulfate, Citric Acid, Red 40

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse thoroughly with water

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if condition worsens or does not improve after regular use of this product 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 right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a condition covers a large area of the body.


Advanced Ingredient Data


Raw Label Data

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