Therapeutic
Coal Tar
Wal-mart Stores, Inc
Human Otc Drug
NDC 49035-009Therapeutic also known as Coal Tar is a human otc drug labeled by 'Wal-mart Stores, Inc'. National Drug Code (NDC) number for Therapeutic is 49035-009. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Therapeutic drug includes Coal Tar - 25 mg/mL . The currest status of Therapeutic drug is Active.
Drug Information:
| Drug NDC: | 49035-009 |
| 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: | Therapeutic |
| 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: | Wal-mart Stores, 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 - 25 mg/mL
|
| 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: | 08 Feb, 2005 |
| 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, 2024 |
| 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: | Wal-Mart Stores, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 309381
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 49035-009-23 | 251 mL in 1 BOTTLE, PLASTIC (49035-009-23) | 08 Feb, 2005 | N/A | No |
| 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:
Purpose anti-dandruff
Product Elements:
Therapeutic coal tar coal tar coal tar water sodium laureth sulfate coco diethanolamide laureth-4 sodium chloride cocamidopropyl betaine methylchloroisothiazolinone methylisothiazolinone citric acid monohydrate edetate sodium caramel fd&c red no. 4
Indications and Usage:
Use controls the symptoms of dandruff seborrheic dermatitis psoriasis
Warnings:
Warnings for external use only
When Using:
When using this product do not get into eyes. if contact occurs, rinse eyes thoroughly with water use caustion in exposing skin to sunlight after applying ths 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 with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor
Dosage and Administration:
Directions wet hair thoroughly massage shampoo into the scalp lather. leave on hair and scalp for several minutes rinse and repeat for best results use at least twice a week or as directed by a doctor
Stop Use:
Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed
Adverse Reactions:
Adverse reactions distributed by: wal-mart stores, inc bentonville, ar 72716 wal-mart stores, inc 205.003/205ag
Package Label Principal Display Panel:
Principal display panel equate compare to neutrogena t/gel therapeutic shampoo active ingredient original strength anti-dandruff formula therapeutic shampoo 2.5% coal tar topical solution usp (0.5% coal tar) relief for itchy, flaky scalp keeps working even after hair has been rinsed controls symptoms of dandruff, psoriasis and seborheic dermatitis transparent formula paraben, phthalate and formaldehyde donor free made in the usa with 90% or more us materials factory certified 8.5 fl oz (251 ml) image description
Further Questions:
Questions or comments? call: 1-888-287-1915