NDC 44911-0138 Trauma Plus

Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum, Calcarea Fluorica, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Natrum Sulphuricum

NDC Product Code 44911-0138

NDC CODE: 44911-0138

Proprietary Name: Trauma Plus 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: Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum, Calcarea Fluorica, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Natrum Sulphuricum 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.

NDC 44911-0138-1

Package Description: 57 g in 1 TUBE

NDC Product Information

Trauma Plus with NDC 44911-0138 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Trauma Plus is calendula officinalis, arnica montana, hypericum perforatum, symphytum officinale, bellis perennis, ledum palustre, sulphuricum acidum, calcarea fluorica, ferrum phosphoricum, rhus tox, ruta graveolens, natrum sulphuricum. 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.

Trauma Plus 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.

  • ARNICA MONTANA 1 [hp_X]/g
  • BELLIS PERENNIS 12 [hp_X]/g
  • CALCIUM FLUORIDE 30 [hp_X]/g
  • CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g
  • COMFREY ROOT 3 [hp_X]/g
  • FERROSOFERRIC PHOSPHATE 30 [hp_X]/g
  • HYPERICUM PERFORATUM 1 [hp_X]/g
  • LEDUM PALUSTRE TWIG 12 [hp_X]/g
  • RUTA GRAVEOLENS FLOWERING TOP 30 [hp_X]/g
  • SODIUM SULFATE 30 [hp_C]/g
  • SULFURIC ACID 12 [hp_X]/g
  • TOXICODENDRON PUBESCENS LEAF 30 [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.

  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • OREGANO (UNII: 0E5AT8T16U)
  • POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SORBIC ACID (UNII: X045WJ989B)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • WHEY (UNII: 8617Z5FMF6)

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.
  • 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: 01-13-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 10-29-2020 What is the End Marketing Date?
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.

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.

Trauma Plus Product Label Images

Trauma Plus 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:

CALENDULA OFFICINALIS 1X, ARNICA MONTANA 1X, 30C, HYPERICUM PERFORATUM 1X, 30C, SYMPHYTUM OFFICINALE 3X, BELLIS PERENNIS 12X, LEDUM PALUSTRE 12X, SULPHURICUM ACIDUM 12X, CALCAREA FLUORICA 30X, FERRUM PHOSPHORICUM 30X, RHUS TOX 30X, RUTA GRAVEOLENS 30X, NATRUM SULPHURICUM 30C

Homeopathic Indications:

For temporary relief of pain associated with bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all minor injuries.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

For temporary relief of pain associated with bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all minor injuries.****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 breast-feeding, 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 small amount every 10 minutes for 3 doses immediately after injury, then 2 to 3 times daily. For topical use only.

Inactive Ingredients:

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (CARBOPOL (ULTREZ 21),  ALOE BARBADENSIS LEAF JUICE (ALOE VERA 10X CONCENTRATE), EDETATE DISODIUM (EDTA), NATURAL PLANT EXTRACT (ORIGANOX WS), [PEG-33, PEG-8 DIMETHICONE, PEG-14 (SILSENSE COPOLYOL-1 SILICONE)], [PHENOXYETHANOL, CAPRYLYL GLYCOL, SORBIC ACID (OPTIPHEN-PLUS)], POTASSIUM SORBATE, PURIFIED WATER, SODIUM HYDROXIDE SOLUTION, TOCOPHEROL [VITAMIN E OIL](DERIVED FROM SOY BEAN), WHEY PROTEIN CONCENTRATE+ (DERIVED FROM MILK)

Questions:

Dist. by Energique, Inc., 201 Apple Blvd.Woodbine, IA 51579     800.869.8078

Package Label Display:

ENERGIQUESINCE 1987HOMEOPATHIC REMEDYTRAUMA+GELNet wt. 2 oz. (57 g)

* Please review the disclaimer below.