Revitaderm Psoriasis
Coal Tar
Blaine Labs Inc.
Human Otc Drug
NDC 63347-112Revitaderm Psoriasis also known as Coal Tar is a human otc drug labeled by 'Blaine Labs Inc.'. National Drug Code (NDC) number for Revitaderm Psoriasis is 63347-112. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Revitaderm Psoriasis drug includes Coal Tar - 2 mg/100mL . The currest status of Revitaderm Psoriasis drug is Active.
Drug Information:
| Drug NDC: | 63347-112 |
| 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: | Revitaderm Psoriasis |
| 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: | Blaine Labs Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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 - 2 mg/100mL
|
| 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 Nov, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 Jun, 2026 |
| 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: | Blaine Labs Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 317080
1297944
|
| 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 |
|---|
| 63347-112-01 | 118 mL in 1 JAR (63347-112-01) | 01 Nov, 2011 | 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 section purpose psoriasis/sebhorreic dermatitis treatment
Product Elements:
Revitaderm psoriasis coal tar coal tar coal tar silver arctium lappa root tea tree oil lavender oil chamaemelum nobile flower water xanthan gum aloe glycerin propylene glycol safflower oil dimethicone alkyl (c12-15) benzoate cetostearyl alcohol glyceryl monostearate peg-100 stearate cetyl alcohol hydrocortisone trolamine phenoxyethanol methylparaben butylparaben ethylparaben propylparaben
Indications and Usage:
Uses section uses for the relief of symptoms associated with psoriasis and or seborrheic dermatitis including itching, scaling, flaking, redness and irritation of the skin. helps prevent recurrences. treats eczema.
Warnings:
Warnings section warnings for external use only. ask a doctor before use for prolonged periods if condition covers a large area of the body around the rectum or in the genital area or groin with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs.
Dosage and Administration:
Directions section directions apply to affected areas as directed by a doctor. apply as needed to affected areas as often as needed (up to four times per day)
Package Label Principal Display Panel:
Package label section dr. blaine's revitaderm psoriasis treatment ndc #63347-112-01 08800-01 rev 20111013 proven formula formulated specifically to address the many symptoms of psoriasis and eczema utilizing specially selected ingredients for maximum benefit. infused with the antimicrobial power of colloidal silver to help prevent infection. dr. blaine's 800 307-8818 info@drblaines.com www.drblaines.com blaine labs, inc. santa fe springs, ca 90670 premium skin care products helps fight infection also relieves eczema sebhorreic dermatitis itching flaking more powerful faster acting reduce odor doctor developed 4 fl. oz our guarantee 100% guaranteed money back rick free quality promise revitaderm psoriiasis ointment is guaranteed to temporarily help soothe and relieve the kin symptoms associated with psoriasis, eczema, and sebhorreic dermatitis to reduce itching, flaking, redness, and scaling. please recycle! this package is made from recyclable materails. proudly made in the u.s.a. res blaine_revitaderm_psoriasis1 blaine_revitaderm_psoriasis2
Further Questions:
Questions or comments? section questions or comments? call (800) 307-8818, monday through friday, 8:00 am to 5:00 pm (pacific time)