70666-016-04

70666-016-04
SPL v4
SPL
SPL Set ID 407bd007-bec6-2864-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Coal Tar (1.39 g)
Inactive Ingredients
Paraffinum Liquidum Water Cetostearyl Alcohol Dmdm Hydantoin Juglans Nigra Leaf Lippia Graveolens Leaf Thymus Vulgaris Leaf Sambucus Nigra Flower Rosmarinus Officinalis Whole Loeselia Mexicana Top .alpha.-hexylcinnamaldehyde Linalool, (+/-)- Geraniol .beta.-citronellol, (r)- Glyceryl Stearate Se Cetyl Palmitate Methylparaben Propylparaben Polysorbate 80 Propylene Glycol Salicylic Acid Limonene, (+)- Polyoxyl 20 Cetostearyl Ether Ceteareth-12 Tropaeolum Majus Saponaria Officinalis Leaf Alpha-isomethyl Ionone Petrolatum Linalool, (+)- Laureth-4 Cocamidopropyl Betaine Sodium Laureth Sulfate Cocamidopropyl Hydroxysultaine Sodium Cocoyl Isethionate Glycol Distearate Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Sodium Chloride Aloe Vera Leaf Glycerin Edetate Disodium Diazolidinyl Urea

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-01

Description

Coal Tar 1.6%


Medication Information

Warnings and Precautions

■ 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.

Description

Coal Tar 1.6%

Use

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

Section 50565-1

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

Section 51727-6

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.

Section 55105-1

Anti-Psoriasis

Anti-Seborrheic Dermatitis

Section 55106-9

Coal Tar 1.6%

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.

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.

Nopsor Psoriasis Pomade

When Using This Product

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

Nopsor Psoriasis Body Wash & Shampoo


Structured Label Content

Use

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

Warnings and Precautions (34071-1)

■ 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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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.

Section 55105-1 (55105-1)

Anti-Psoriasis

Anti-Seborrheic Dermatitis

Section 55106-9 (55106-9)

Coal Tar 1.6%

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.

Other Information (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.

Nopsor Psoriasis Pomade (NOPSOR PSORIASIS POMADE)

When Using This Product (When using this product)

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water

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

Conditions worsens or does not improve after regular use of this product as directed

Nopsor Psoriasis Body Wash & Shampoo (NOPSOR PSORIASIS BODY WASH & SHAMPOO)


Advanced Ingredient Data


Raw Label Data

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