NDC 55714-4440 Oral Care - Gingivitis

Aconitum Nap., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium Majus,crotalus Horridus, Gelsemium, Hepar Sulph.calc., Kreosotum, Merc. Viv., Myrrha, Nux Vom., Phosphorus, Phytolacca, Plantago, Rhus Toxicodendron, Slicea, Staphysag., Echinacea

NDC Product Code 55714-4440

NDC Code: 55714-4440

Proprietary Name: Oral Care - Gingivitis 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: Aconitum Nap., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium Majus,crotalus Horridus, Gelsemium, Hepar Sulph.calc., Kreosotum, Merc. Viv., Myrrha, Nux Vom., Phosphorus, Phytolacca, Plantago, Rhus Toxicodendron, Slicea, Staphysag., Echinacea 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.


Code Structure
  • 55714 - Newton Laboratories, Inc.
    • 55714-4440 - Oral Care - Gingivitis

NDC 55714-4440-1

Package Description: 29.57 mL in 1 BOTTLE, GLASS

NDC 55714-4440-2

Package Description: 59.14 mL in 1 BOTTLE, GLASS

NDC Product Information

Oral Care - Gingivitis with NDC 55714-4440 is a a human prescription drug product labeled by Newton Laboratories, Inc.. The generic name of Oral Care - Gingivitis is aconitum nap., arnica, arsenicum alb., baptisia, belladonna, bryonia, calendula, chamomilla, chelidonium majus,crotalus horridus, gelsemium, hepar sulph.calc., kreosotum, merc. viv., myrrha, nux vom., phosphorus, phytolacca, plantago, rhus toxicodendron, slicea, staphysag., echinacea. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Newton Laboratories, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Prescription 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.


Oral Care - Gingivitis 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.

  • ACONITUM NAPELLUS 20 [hp_X]/mL
  • ARNICA MONTANA 20 [hp_X]/mL
  • ARSENIC TRIOXIDE 20 [hp_X]/mL
  • BAPTISIA TINCTORIA ROOT 20 [hp_X]/mL
  • ATROPA BELLADONNA 20 [hp_X]/mL
  • BRYONIA ALBA ROOT 20 [hp_X]/mL
  • CALENDULA OFFICINALIS FLOWERING TOP 20 [hp_X]/mL
  • MATRICARIA RECUTITA 20 [hp_X]/mL
  • CHELIDONIUM MAJUS 20 [hp_X]/mL
  • CROTALUS HORRIDUS HORRIDUS VENOM 20 [hp_X]/mL
  • GELSEMIUM SEMPERVIRENS ROOT 20 [hp_X]/mL
  • CALCIUM SULFIDE 20 [hp_X]/mL
  • WOOD CREOSOTE 20 [hp_X]/mL
  • MERCURY 20 [hp_X]/mL
  • MYRRH 20 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 20 [hp_X]/mL
  • PHOSPHORUS 20 [hp_X]/mL
  • PLANTAGO MAJOR 20 [hp_X]/mL
  • TOXICODENDRON PUBESCENS LEAF 20 [hp_X]/mL
  • SILICON DIOXIDE 20 [hp_X]/mL
  • DELPHINIUM STAPHISAGRIA SEED 20 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 8 [hp_X]/mL

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.

  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Plant Proteins - [CS]
  • Seed Storage Proteins - [CS]

Product Labeler Information

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

* Please review the disclaimer below.

Oral Care - Gingivitis Product Label Images

Oral Care - Gingivitis 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

Indications & Usage Section

Oral Care - Gingivitis   Formulated for symptoms associated with periodontal conditions such as mouth ulcerations, gingivitis, halitosis, teeth pain and gum sensitivity.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.

Active Ingredient Section

Aconitum nap. 20x, Arnica 20x, Arsenicum alb. 20x, Baptisia 20x, Belladonna 20x, Bryonia 20x, Calendula 20x, Chamomilla 20x, Chelidonium majus 20x, Crotalus horridus 20x, Gelsemium 20x, Hepar sulph. calc. 20x, Kreosotum 20x, Merc. viv. 20x, Myrrha 20x, Nux vom. 20x, Phosphorus 20x, Phytolacca 20x, Plantago 20x, Rhus toxicodendron 20x, Silicea 20x, Staphysag. 20x, Chamomilla 8x, Echinacea 8x, Chamomilla 3x, Echinacea 3x.

Purpose Section

Formulated for symptoms associated with periodontal conditions such as mouth ulcerations, gingivitis, halitosis, teeth pain and gum sensitivity.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

Questions? Section

Www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012Questions?  1.800.448.7256

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days

Keep Out Of Reach Of Children Section

Keep out of reach of children

* Please review the disclaimer below.

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