Coal Tar Shampoo
FDA Label NDC 70666-022
11 label sections · Submitted to the FDA by Nopsor Usa Distribution Co., Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nopsor Usa Distribution Co., Inc. for the product Coal Tar (NDC 70666-022). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding nopsor psoriasis pomade, otc - active ingredient, otc - purpose, use, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Coal Tar 1.6%
Coal Tar 2.2%
Otc - Purpose
Anti-Psoriasis
Anti-Seborrheic Dermatitis
Anti-Psoriasis
Anti-Dandruff
Anti-Seborrheic Dermatitis
Use
For the relief of skin itching, scaling, flaking, redness, and irritation associated with psoriasis and/or seborrheic dermatitis. Helps prevent recurrence.
For the relief of itching, irritation, redness, flacking and scaling associated with ■ Psoriasis ■ Dandruff ■ Seborrheic Dermatitis.
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.
When Using This Product
Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water
Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water
Stop Use And Ask A Doctor If
Conditions worsens or does not improve after regular use of this product as directed
Conditions worsens or does not improve after regular use of this product as directed
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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.
■ 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.
Other Information
■ See on the bottom of the bottle for lot number and expiration date.
■ Store at room temperature between 68°F (20°C) and 77°F (25°C).
■ In rare instances discoloration of gray, blonde, bleached or tinted hair may occur.
■ See on the bottom of the bottle for lot number and expiration date.
■ Store at room temperature between 68°F (20°C) and 77°F (25°C).
■ In rare instances discoloration of gray, blonde, bleached or tinted hair may occur.
Inactive Ingredient
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.
* Please review the disclaimer below.
