MedPath

Coal Tar

70666-016-04 70666-022-08

Approved
Approval ID

407bd007-bec6-2864-e054-00144ff88e88

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 5, 2025

Manufacturers
FDA

Nopsor USA Distribution Co., Inc.

DUNS: 080169619

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Coal Tar

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70666-022
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
Coal Tar
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 5, 2025
FDA Product Classification

INGREDIENTS (32)

METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
JUGLANS NIGRA LEAFInactive
Code: I2OQ2W1NI2
Classification: IACT
THYMUS VULGARIS LEAFInactive
Code: GRX3499643
Classification: IACT
ROSMARINUS OFFICINALIS WHOLEInactive
Code: EA3289138M
Classification: IACT
.ALPHA.-HEXYLCINNAMALDEHYDEInactive
Code: 7X6O37OK2I
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
LINALOOL, (+)-Inactive
Code: F4VNO44C09
Classification: IACT
GERANIOLInactive
Code: L837108USY
Classification: IACT
LIMONENE, (+)-Inactive
Code: GFD7C86Q1W
Classification: IACT
LAURETH-4Inactive
Code: 6HQ855798J
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
COAL TARActive
Quantity: 5.39 g in 250 mL
Code: R533ESO2EC
Classification: ACTIB
SODIUM LAURETH SULFATEInactive
Code: BPV390UAP0
Classification: IACT
COCAMIDOPROPYL HYDROXYSULTAINEInactive
Code: 62V75NI93W
Classification: IACT
SODIUM COCOYL ISETHIONATEInactive
Code: 518XTE8493
Classification: IACT
GLYCOL DISTEARATEInactive
Code: 13W7MDN21W
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SALICYLIC ACIDInactive
Code: O414PZ4LPZ
Classification: IACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)Inactive
Code: 0L414VCS5Y
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
LIPPIA GRAVEOLENS LEAFInactive
Code: 99B56I78PQ
Classification: IACT
TROPAEOLUM MAJUSInactive
Code: 9G6ZOS4L87
Classification: IACT
SAPONARIA OFFICINALIS LEAFInactive
Code: 3988313MM7
Classification: IACT
LOESELIA MEXICANA TOPInactive
Code: BYW8H93R0X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIAZOLIDINYL UREAInactive
Code: H5RIZ3MPW4
Classification: IACT
SAMBUCUS NIGRA FLOWERInactive
Code: 07V4DX094T
Classification: IACT
.BETA.-CITRONELLOL, (R)-Inactive
Code: P01OUT964K
Classification: IACT

Coal Tar

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70666-016
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
Coal Tar
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 5, 2025
FDA Product Classification

INGREDIENTS (29)

PARAFFINUM LIQUIDUMInactive
Code: T5L8T28FGP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
JUGLANS NIGRA LEAFInactive
Code: I2OQ2W1NI2
Classification: IACT
LIPPIA GRAVEOLENS LEAFInactive
Code: 99B56I78PQ
Classification: IACT
THYMUS VULGARIS LEAFInactive
Code: GRX3499643
Classification: IACT
SAMBUCUS NIGRA FLOWERInactive
Code: 07V4DX094T
Classification: IACT
ROSMARINUS OFFICINALIS WHOLEInactive
Code: EA3289138M
Classification: IACT
LOESELIA MEXICANA TOPInactive
Code: BYW8H93R0X
Classification: IACT
.ALPHA.-HEXYLCINNAMALDEHYDEInactive
Code: 7X6O37OK2I
Classification: IACT
LINALOOL, (+/-)-Inactive
Code: D81QY6I88E
Classification: IACT
GERANIOLInactive
Code: L837108USY
Classification: IACT
.BETA.-CITRONELLOL, (R)-Inactive
Code: P01OUT964K
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
CETYL PALMITATEInactive
Code: 5ZA2S6B08X
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SALICYLIC ACIDInactive
Code: O414PZ4LPZ
Classification: IACT
LIMONENE, (+)-Inactive
Code: GFD7C86Q1W
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
CETEARETH-12Inactive
Code: 7V4MR24V5P
Classification: IACT
TROPAEOLUM MAJUSInactive
Code: 9G6ZOS4L87
Classification: IACT
SAPONARIA OFFICINALIS LEAFInactive
Code: 3988313MM7
Classification: IACT
ALPHA-ISOMETHYL IONONEInactive
Code: 9XP4LC555B
Classification: IACT
COAL TARActive
Quantity: 1.39 g in 100 mL
Code: R533ESO2EC
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/1/2016

NOPSOR PSORIASIS BODY WASH & SHAMPOO

NOPSOR PSORIASIS BODY WASH

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.

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