NDC 63347-112 Revitaderm Psoriasis

Coal Tar

NDC Product Code 63347-112

NDC 63347-112-01

Package Description: 118 mL in 1 JAR

NDC Product Information

Revitaderm Psoriasis with NDC 63347-112 is a a human over the counter drug product labeled by Blaine Labs Inc.. The generic name of Revitaderm Psoriasis is coal tar. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Blaine Labs Inc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Revitaderm Psoriasis Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • COAL TAR 2 mg/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SILVER (UNII: 3M4G523W1G)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ALOE (UNII: V5VD430YW9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • HYDROCORTISONE (UNII: WI4X0X7BPJ)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Blaine Labs Inc.
Labeler Code: 63347
FDA Application Number: part358H What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 11-01-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Revitaderm Psoriasis Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients Section

Drug Facts  Active Ingredient Coal Tar (2%)

Purpose Section

Purpose  Psoriasis/Sebhorreic Dermatitis Treatment

Keep Out Of Reach Of Children Section

Enter section text here

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 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.

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)

Inactive Ingredient Section

Inactive Ingredients  Colloidal Silver, Burdock Root, Tea Tree Oil, Lavender Oil, Chamomile Extract, Water, Xanthan Gum, Aloe 200X, Glycerin, Propylene Glycol, Safflower Oil, Dimethicone, C12/15 Alky Benzoate, Emulsifying Wax, Glycerol Stearate and PEG 100 Stearate, Cetyl Alcohol, Phenonip (phenoxyethanol, methylparaben, butylparaben, ethylparaben, propylparaben), Hydrocortisone, Triethanolamine.

Package Label Section

Dr. Blaine's RevitaDERM PSORIASIS TREATMENTNDC #63347-112-01  08800-01 Rev 20111013PROVEN FORMULAFormulated 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  [email protected]  www.DrBlaines.com  Blaine Labs, Inc. Santa Fe Springs, CA 90670PREMIUM SKIN CARE PRODUCTS  HELPS FIGHT INFECTIONAlso Relieves Eczema  Sebhorreic Dermatitis  Itching  Flaking  More Powerful  Faster Acting  Reduce Odor  DOCTOR DEVELOPED4 fl. ozOUR GUARANTEE  100% GUARANTEED Money Back  Rick Free  QUALITY PROMISERevitaDerm  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.

* Please review the disclaimer below.