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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

COAL TAR: 69 Adverse Event Reports & Safety Profile

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69
Total FAERS Reports
1 (1.4%)
Deaths Reported
6
Hospitalizations
69
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities
Neoteric Cosmetics, Inc.
Manufacturer

Route: TOPICAL · Manufacturer: Neoteric Cosmetics, Inc. · HUMAN OTC DRUG · FDA Label: Available

First Report: 20000101 · Latest Report: 20250101

What Are the Most Common COAL TAR Side Effects?

#1 Most Reported
Drug ineffective
19 reports (27.5%)
#2 Most Reported
Psoriasis
11 reports (15.9%)
#3 Most Reported
Pruritus
10 reports (14.5%)

All COAL TAR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 19 27.5% 0 0
Psoriasis 11 15.9% 0 2
Pruritus 10 14.5% 0 0
Therapeutic product effect incomplete 9 13.0% 0 1
Product use in unapproved indication 5 7.3% 0 0

Who Reports COAL TAR Side Effects? Age & Gender Data

Gender: 62.9% female, 37.1% male. Average age: 47.0 years. Most reports from: US. View detailed demographics →

Is COAL TAR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 1
2013 1 0 0
2014 2 0 0
2015 5 0 0
2016 1 0 0
2017 1 0 0
2018 2 0 0
2020 2 0 0
2023 1 0 0
2024 1 0 0
2025 1 0 0

View full timeline →

What Is COAL TAR Used For?

IndicationReports
Psoriasis 29
Product used for unknown indication 18

Official FDA Label for COAL TAR

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Use For the relief of skin itching, scaling, flaking, redness, and irritation associated with psoriasis and/or seborrheic dermatitis. Helps prevent recurrence.

Use

For the relief of itching, irritation, redness, flacking and scaling associated with ■ Psoriasis ■ Dandruff ■ Seborrheic Dermatitis.

Dosage & Administration

Directions ■ Wash affected areas at least once daily with mild soap and warm water and dry thoroughly. ■ Apply a small amount of NOPSOR pomade to affected areas after removing loose scales, one to four times daily or as directed by a doctor. Massage well. ■ Intended for use by normally healthy adults only. ■ Persons under 18 years of age, or those with highly sensitive or allergic skin should only use as directed by a doctor.

Directions ■ Shake well before use ■ Use on affected areas in place of your regular soap or shampoo. ■ Wet hair and/or skin thoroughly, then massage a liberal amount of NOPSOR Body Wash and Shampoo into the affected area and leave on for several minutes. ■ Rinse thoroughly and repeat. ■ For best results, use at least twice a week or as directed by a doctor.

Warnings

■ For external use only. ■ Use only as directed. ■ Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application. ■ Do not use for prolonged periods without consulting a doctor. ■ Do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor. ■ If condition covers a large area of the body, consult your doctor before using this product. ■ Do not use this product in or around the rectum or in the genital area or groin except on the advice of a doctor. ■ Do not use on wounds or damaged skin, or on a child under 12 years of age unless directed by a doctor.

■ For external use only. ■ Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application. ■ Do not use for prolonged periods without consulting a doctor. ■ Do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor. ■ If condition covers a large area of the body, consult your doctor before using this product ■ Do not use on wounds or damaged skin, or on a child under 12 years of age unless directed by a doctor.

Active Ingredient

Drug Facts Active Ingredient Coal Tar 3% (from Coal Tar Topical Solution, USP 20%)

Inactive Ingredients

Petrolatum, Propylene Glycol, Fragrance (Parfum), Salicylic Acid, Polysorbate 80, Glyceryl Stearate, Ceteareth-20, Ceteareth-12, Cetearyl Alcohol, Cetyl Palmitate, Juglans Sp.

Leaf

Extract, Lippia Sp.

Leaf

Extract, Thymus Vulgaris Leaf Extract, Sambucus Sp.

Flower

Extract, Rosmarinus Officinalis Leaf Extract, Tropaeolum Majus Leaf Extract, Saponaria Officinalis Leaf Extract, Loeselia Mexicana L.

Leaf

Extract, Paraffinum Liquidum, Water (Aqua), DMDM Hydantoin, Methylparaben, Propylparaben, Hexyl Cinnamal, Linalool, Geraniol, Limonene, Citronellol, Alpha-Isomethyl Ionone.

Water (Aqua), Sodium Laureth Sulfate, Sodium Cocoyl Isethionate, Cocamidopropyl Hydroxysultaine, Propylene Glycol, Fragrance (Parfum), Salicylic Acid, Glycol Distearate, Sodium Chloride, Laureth 4, Cocamidopropyl Betaine, Polyquaternium-7, Aloe Barbadensis Leaf Extract, Glycerin, Disodium EDTA, Juglans Sp.

Leaf

Extract, Lippia Sp.

Leaf

Extract, Thymus Vulgaris Leaf Extract, Sambucus Sp.

Flower

Extract, Rosmarinus Officinalis Leaf Extract, Tropaeolum Majus Leaf Extract, Saponaria Officinalis Leaf Extract, Loeselia Mexicana L.

Leaf

Extract, DMDM Hydantoin, Diazolidinyl Urea, Methylparaben, Propylparaben, Hexyl Cinnamal, Linalool, Geraniol, Limonene, Citronellol.