NDC 55714-2394 Breast Care

Bufo Rana, Apis Mel., Asterias Rubens, Belladonna, Bryonia, Calc. Carb., Chamomilla, Chimaphila Umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias Dioica, Lachesis, Merc. Viv., Phellandrium Aquaticum Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, Taraxacum

NDC Product Code 55714-2394

NDC CODE: 55714-2394

Proprietary Name: Breast Care 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: Bufo Rana, Apis Mel., Asterias Rubens, Belladonna, Bryonia, Calc. Carb., Chamomilla, Chimaphila Umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias Dioica, Lachesis, Merc. Viv., Phellandrium Aquaticum Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, Taraxacum 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

  • 55714 - Newton Laboratories, Inc.

NDC 55714-2394-1

Package Description: 30 mL in 1 BOTTLE, GLASS

NDC Product Information

Breast Care with NDC 55714-2394 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Breast Care is bufo rana, apis mel., asterias rubens, belladonna, bryonia, calc. carb., chamomilla, chimaphila umbellata, cinchona, conium, croton, echinacea, graphites, helonias dioica, lachesis, merc. viv., phellandrium aquaticum phosphorus, phytolacca, pulsatilla, sanguinaria, silicea, hamamelis, ruta, taraxacum. 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 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.

Breast Care 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.

  • BUFO BUFO CUTANEOUS GLAND 15 [hp_X]/mL
  • APIS MELLIFERA 15 [hp_X]/mL
  • ASTERIAS RUBENS 15 [hp_X]/mL
  • ATROPA BELLADONNA 15 [hp_X]/mL
  • BRYONIA ALBA ROOT 15 [hp_X]/mL
  • OYSTER SHELL CALCIUM CARBONATE, CRUDE 15 [hp_X]/mL
  • MATRICARIA RECUTITA 15 [hp_X]/mL
  • CHIMAPHILA UMBELLATA 15 [hp_X]/mL
  • CINCHONA OFFICINALIS BARK 15 [hp_X]/mL
  • CONIUM MACULATUM FLOWERING TOP 15 [hp_X]/mL
  • CROTON TIGLIUM SEED 15 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 15 [hp_X]/mL
  • GRAPHITE 15 [hp_X]/mL
  • CHAMAELIRIUM LUTEUM ROOT 15 [hp_X]/mL
  • LACHESIS MUTA VENOM 15 [hp_X]/mL
  • MERCURY 15 [hp_X]/mL
  • OENANTHE AQUATICA FRUIT 15 [hp_X]/mL
  • PHOSPHORUS 15 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 15 [hp_X]/mL
  • PULSATILLA VULGARIS 15 [hp_X]/mL
  • SANGUINARIA CANADENSIS ROOT 15 [hp_X]/mL
  • SILICON DIOXIDE 15 [hp_X]/mL
  • HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6 [hp_X]/mL
  • RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X]/mL
  • TARAXACUM OFFICINALE 6 [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.

  • WATER (UNII: 059QF0KO0R)
  • 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.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Newton Laboratories, Inc.
Labeler Code: 55714
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: 11-05-2018 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: 12-31-2020 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.

Breast Care Product Label Images

Breast Care 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

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

Questions Section

Newtonlabs.net - Questions? 800 448-7256Newton Laboratories, Inc. FDA Est. # 1051203 - Conyers, GA 30013

Otc - Pregnancy Or Breast Feeding Section

If
pregnant or breast-feeding, ask a doctor before use.

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If
pregnant or breast-feeding, ask a doctor before use.

Inactive Ingredient Section

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Otc - Purpose Section

Formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

Otc - Active Ingredient Section

Equal parts of Hamamelis 6x, Phytolacca 6x, Ruta 6x, Taraxacum 6x, Apis mel. 15x, Asterias 15x, Belladonna 15x, Bryonia 15x, Bufo 15x, Calc. carb. 15x, Chamomilla 15x, Chimaphila umb. 15x, Cinchona 15x, Conium 15x, Croton 15x, Echinacea 15x, Graphites 15x, Helonias 15x, Lachesis 15x, Merc. viv. 15x, Phellandrium 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Sanguinaria 15x, Silicea 15x.

Dosage & Administration Section

Ages 12 and up take 6 drops by mouth one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Indications & Usage Section

Formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

* Please review the disclaimer below.