Label: COAL TAR ointment
COAL TAR shampoo
- NDC Code(s): 70666-016-04, 70666-022-08
- Packager: Nopsor USA Distribution Co., Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 1, 2022
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PRINCIPAL DISPLAY PANEL
Petrolatum, Propylene Glycol, Parfum, Salicylic Acid, Polysorbate 80, Glyceryl Stearate, Ceteareth-20, Ceteareth-12, Cetearyl Alcohol, Cetyl Palmitate, DMDM Hydantoin , Methylparaben, Propylparaben, Junglas Sp Leaf Extract, Lippia Sp Leaf Extract, Thymus Vulgaris Leaf Extract, Sambucus Sp Flower Extract, Rosmarinus Officinalis Extract, Tropaeolum Majus Leaf Extract, Saponaria Officinalis Leaf Extract, Loeselia Mexicana L. Leaf Extract , Hexyl Cinnamic Aldehyde, Butylphenyl Methylpropional, Linalool, Geraniol, Limonene, Citronellol.
Directions:
Use only as directed. Apply a small amount of NOPSOR pomade to affected areas once a day or as directed by a doctor. Massage well into affected areas after removing loose scales. Wash affected areas at least daily with mild soap and warm water and dry thoroughly. 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.
When using this product Avoid contact with the eyes. If contact occurs, rinse thoroughly with water. • 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 physician. • If condition worsens or does not improve after regular use of this product as directed, consult a doctor. • Do not use for prolonged periods without consulting a physician. • If condition covers a large area of the body, consult your physician before using this product. • 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. Warning: This product contains chemicals known to the state of California to cause cancer.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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PRINCIPAL DISPLAY PANEL
Aqua, Sodium Laureth Sulfate, Cocamidopropyl Hydroxysultaine, Sodium Cocoyl Isethionate, Glycol Distearate, Laureth 4, Cocamidopropyl Betaine, Propylene Glycol, Parfum, Salicylic Acid, Polyquaternium-7, Sodium Chloride, Aloe Barbadensis Leaf Extract, Glycerin, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben , Junglas sp leaf extract, Lippia sp leaf extract, Thymus vulgaris extract, Sambucus sp flower extract, Rosmarinus officinalis extract, Tropaeolum majus leaf extract, Saponaria officinalis leaf extract, Loeselia mexicana L. leaf extract, Hexyl Cinnamic Aldehyde, Butylphenyl Methylpropional, Linalool, Geraniol, Limonene, Citronellol.
Directions:
Shake well before use. Wet hair thoroughly, then massage a liberal amount of NOPSOR Body Wash and Shampoo into the scalp and/or skin and leave on for several minutes. Rinse thoroughly and repeat. For best results, use at least twice a week or as directed by a physician.
When using this product avoid contact with the eyes. If contact occurs, rinse thoroughly with water. • 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 physician. • If condition worsens or does not improve after regular use of this product as directed, consult a doctor. • Do not use for prolonged periods without consulting a physician. • If condition covers a large area of the body, consult your physician before using this product. • 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. Warning: This product contains chemicals known to the state of California to cause cancer.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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INGREDIENTS AND APPEARANCE
COAL TAR
coal tar ointmentProduct 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 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 OIL (UNII: Q35633V53D) ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L) 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) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 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 final part358H 12/01/2016 COAL TAR
coal tar shampooProduct 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 FLOWERING TOP (UNII: 8JM482TI79) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 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 final part358H 12/01/2016 Labeler - Nopsor USA Distribution Co., Inc. (080169619) Registrant - Chemco Corporation (032495954) Establishment Name Address ID/FEI Business Operations Chemco Corporation 032495954 manufacture(70666-022, 70666-016)