COAL TAR ointment COAL TAR shampoo

Coal Tar by

Drug Labeling and Warnings

Coal Tar by is a Otc medication manufactured, distributed, or labeled by Nopsor USA Distribution Co., Inc., Chemco Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NOPSOR PSORIASIS POMADE

Coal Tar 1.6%

Anti-Psoriasis

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 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.

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

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.

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.

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.

NOPSOR PSORIASIS BODY WASH & SHAMPOO

Coal Tar 2.2%

Anti-Psoriasis

Anti-Dandruff

Anti-Seborrheic Dermatitis

Use

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

■ 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

Stop use and ask a doctor if

Conditions 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 immediately.

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.

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.

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.

INGREDIENTS AND APPEARANCE

COAL TAR 
coal tar ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70666-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	1.39 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PARAFFINUM LIQUIDUM (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DMDM HYDANTOIN (UNII: BYR0546TOW)
JUGLANS NIGRA LEAF (UNII: I2OQ2W1NI2)
LIPPIA GRAVEOLENS LEAF (UNII: 99B56I78PQ)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
LOESELIA MEXICANA TOP (UNII: BYW8H93R0X)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SALICYLIC ACID (UNII: O414PZ4LPZ)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETEARETH-12 (UNII: 7V4MR24V5P)
TROPAEOLUM MAJUS (UNII: 9G6ZOS4L87)
SAPONARIA OFFICINALIS LEAF (UNII: 3988313MM7)
ALPHA-ISOMETHYL IONONE (UNII: 9XP4LC555B)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70666-016-04	125 mL in 1 JAR; Type 0: Not a Combination Product	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	12/01/2016

COAL TAR 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70666-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	5.39 g  in 250 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
JUGLANS NIGRA LEAF (UNII: I2OQ2W1NI2)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
DMDM HYDANTOIN (UNII: BYR0546TOW)
LINALOOL, (+)- (UNII: F4VNO44C09)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LAURETH-4 (UNII: 6HQ855798J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SALICYLIC ACID (UNII: O414PZ4LPZ)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LIPPIA GRAVEOLENS LEAF (UNII: 99B56I78PQ)
TROPAEOLUM MAJUS (UNII: 9G6ZOS4L87)
SAPONARIA OFFICINALIS LEAF (UNII: 3988313MM7)
LOESELIA MEXICANA TOP (UNII: BYW8H93R0X)
WATER (UNII: 059QF0KO0R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70666-022-08	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	12/01/2016

Labeler - Nopsor USA Distribution Co., Inc. (080169619)