NDC 44911-0366 Psoriasis

Hydrocotyle Asiatica, Lappa Major, Arsenicum Album Arsenicum Iodatum, Borax, Graphites, Mezereum, Natrum Muriaticum, Petroleum, Phytolacca Decandra, Sepia, Kali Arsenicosum

NDC Product Code 44911-0366

NDC Code: 44911-0366

Proprietary Name: Psoriasis What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydrocotyle Asiatica, Lappa Major, Arsenicum Album Arsenicum Iodatum, Borax, Graphites, Mezereum, Natrum Muriaticum, Petroleum, Phytolacca Decandra, Sepia, Kali Arsenicosum What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 44911 - Energique, Inc.
    • 44911-0366 - Psoriasis

NDC 44911-0366-1

Package Description: 57 g in 1 TUBE

NDC Product Information

Psoriasis with NDC 44911-0366 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Psoriasis is hydrocotyle asiatica, lappa major, arsenicum album arsenicum iodatum, borax, graphites, mezereum, natrum muriaticum, petroleum, phytolacca decandra, sepia, kali arsenicosum. The product's dosage form is gel and is administered via topical form.

Labeler Name: Energique, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

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.

  • CENTELLA ASIATICA 1 [hp_X]/g
  • ARCTIUM LAPPA ROOT 1 [hp_X]/g
  • ARSENIC ACID 12 [hp_X]/g
  • ARSENIC TRIOXIDE 12 [hp_X]/g
  • SODIUM BORATE 12 [hp_X]/g
  • GRAPHITE 12 [hp_X]/g
  • DAPHNE MEZEREUM BARK 12 [hp_X]/g
  • SODIUM CHLORIDE 12 [hp_X]/g
  • PETROLATUM 12 [hp_X]/g
  • PHYTOLACCA AMERICANA ROOT 12 [hp_X]/g
  • SEPIA OFFICINALIS JUICE 12 [hp_X]/g
  • POTASSIUM ARSENITE ANHYDROUS 16 [hp_X]/g

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.

  • WATER (UNII: 059QF0KO0R)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • WHEY (UNII: 8617Z5FMF6)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SORBIC ACID (UNII: X045WJ989B)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • OREGANO (UNII: 0E5AT8T16U)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

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: Energique, Inc.
Labeler Code: 44911
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 06-16-2016 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: 12-31-2019 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Psoriasis Product Label Images

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:

Hydrocotyle Asiatica 1X, Lappa Major 1X, Arsenicum Album 12, Arsenicum Iodatum 12X, Borax 12X, Graphites 12X, Mezereum 12X, Natrum Muriaticum 12X, Petroleum 12X, Phytolacca Decandra 12X, Sepia 12X, Kali Arsenicosum 16X

Indiccations:

For temporary relief of burning and scaling due to psoriasis.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings:

For external use only. If an adverse reaction occurs, discontinue use.If pregnant or breastfeeding, ask a health professional before use.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Do not use if tamper evident seal is broken or missing.Store in a cool, dry place.Do not expose product to extreme temperatures.

Keep Out Of Reach Of Children:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply topically to affected area 4 times daily.

Indications:

For temporary relief of burning and scaling due to psoriasis.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Inactive Ingredients:

Purified Water, Grape seed Oil (Seed), Whey Protein Concentrate, Lecithin (Soy), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acetate Crosspolymer, Aloe Barbadensis Leaf Juice, Polysorbate 20, Sodium Hydroxide (Solution), Tocopherol (Vitamin E Oil), Edetate Disodium, Oregano, Potassium Sorbate

Questions:

Dist. by Energique, Inc.201 Apple Blvd.Woodbine, IA 51579    800.868.8078

Package Label Display:

ENERGIQUESINCE 1987HOMEOPATHIC REMEDYPSORIASIS GELNet Wt. 2 oz. (57 g)

* Please review the disclaimer below.

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