COAL TAR: 69 Adverse Event Reports & Safety Profile
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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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is COAL TAR Used For?
| Indication | Reports |
|---|---|
| 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.