Package Label.Principal Display Panel
Bodywash_8oz (Bodywash 8oz)
Coal Tar Ointment
FDA Label NDC 70666-016
Full FDA labeling including 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 70666-016). 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 package label.principal display panel, inactive ingredient, dosage & administration, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
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.
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.
Dosage & Administration
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.
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.
Indications & Usage
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.
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.
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.
Otc - Purpose
For the relief of symptoms associated with Psoriasis and/or Seborrheic Dermatitis including:
Itching, Scaling, Flaking, Redness, Irritation of the skin - Helps prevent recurrence.
For the relief of symptoms associated with Psoriasis, Seborrheic Dermatitis and/or Dandruff including: Itching, Scaling, Flaking, Redness, Irritation of the scalp - Helps prevent recurrence.
Otc - Active Ingredient
ACTIVE INGREDIENT: Coal Tar 1.6% …….. Purpose: Psoriasis/Seborrheic Dermatitis
ACTIVE INGREDIENT: Coal Tar 2.2% ……... Purpose: Psoriasis, Seborrheic Dermatitis, Dandruff Treament
Warnings
Warnings
For external use only. Use only as directed.
Warnings
For external use only.
* Please review the disclaimer below.
