Coal Tar


Nopsor Usa Distribution Co., Inc.
Human Otc Drug
NDC 70666-022
Coal Tar is a human otc drug labeled by 'Nopsor Usa Distribution Co., Inc.'. National Drug Code (NDC) number for Coal Tar is 70666-022. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Coal Tar drug includes Coal Tar - 5.39 g/250mL . The currest status of Coal Tar drug is Active.

Drug Information:

Drug NDC: 70666-022
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Coal Tar
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Coal Tar
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Nopsor Usa Distribution Co., Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Shampoo
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:COAL TAR - 5.39 g/250mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 01 Dec, 2016
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 22 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part358H
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Nopsor USA Distribution Co., Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0755439357927
0755439357910
UPC stands for Universal Product Code.
UNII:R533ESO2EC
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
70666-022-08250 mL in 1 BOTTLE, PLASTIC (70666-022-08)01 Dec, 2016N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

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.

Product Elements:

Coal tar coal tar cetostearyl alcohol dmdm hydantoin juglans nigra leaf lippia graveolens leaf thymus vulgaris leaf sambucus nigra flower oil rosmarinus officinalis flowering top oil 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 butylphenyl methylpropional coal tar coal tar petrolatum coal tar coal tar methylparaben juglans nigra leaf thymus vulgaris leaf rosmarinus officinalis flowering top .alpha.-hexylcinnamaldehyde butylphenyl methylpropional linalool, (+)- geraniol limonene, (+)- laureth-4 cocamidopropyl betaine coal tar coal tar sodium laureth sulfate cocamidopropyl hydroxysultaine sodium cocoyl isethionate glycol distearate propylene glycol salicylic acid polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) sodium chloride aloe vera leaf glycerin edetate disodium propylparaben lippia graveolens leaf tropaeolum majus saponaria officinalis leaf loeselia mexicana top water diazolidinyl urea sambucus nigra flower .beta.-citronellol, (r)-

Indications and 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.

Warnings:

Warnings for external use only. use only as directed.

Warnings for external use only.

Dosage and 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.

Package Label Principal Display Panel:

Pomade 4 oz 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. for the relief of symptoms associated with psoriasis and/or seborrheic dermatitis including: itching, scaling, flaking, redness, irritation of the skin - helps prevent recurrence. active ingredient: coal tar 1.6% …….. purpose: psoriasis/seborrheic dermatitis warnings for external use only. use only as directed.

Bodywash_8oz 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. 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. active ingredient: coal tar 2.2% ……... purpose: psoriasis, seborrheic dermatitis, dandruff treament warnings for external use only.


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.