NDC 55714-4790 Acne - Cystic Acne

Echinacea, Juglans Regia, Lappa Major, Taraxacum Officinale, Antimonium Crudum, Arsenicum Album, Aurum Metallicum, Berberis Aquifolium, Bovista, Carbo Vegetabilis, Causticum, Chelidonium Majus, Dulcamara, Graphites, Hepar Sulphuris Calcareum, Hydrocotyle Asiatica, Kali Bromatum, Kali Iodatum, Ledum Palustre, Lycopdium Clavatum, Nux Vomica, Sulphur Iodatum, Zincum Metallicum, Silicea

NDC Product Code 55714-4790

NDC Code: 55714-4790

Proprietary Name: Acne - Cystic Acne 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: Echinacea, Juglans Regia, Lappa Major, Taraxacum Officinale, Antimonium Crudum, Arsenicum Album, Aurum Metallicum, Berberis Aquifolium, Bovista, Carbo Vegetabilis, Causticum, Chelidonium Majus, Dulcamara, Graphites, Hepar Sulphuris Calcareum, Hydrocotyle Asiatica, Kali Bromatum, Kali Iodatum, Ledum Palustre, Lycopdium Clavatum, Nux Vomica, Sulphur Iodatum, Zincum Metallicum, Silicea 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 55714-4790-1

Package Description: 30 mL in 1 BOTTLE, GLASS

NDC Product Information

Acne - Cystic Acne with NDC 55714-4790 is a a human over the counter drug product labeled by Newton Laboratories, Inc. The generic name of Acne - Cystic Acne is echinacea, juglans regia, lappa major, taraxacum officinale, antimonium crudum, arsenicum album, aurum metallicum, berberis aquifolium, bovista, carbo vegetabilis, causticum, chelidonium majus, dulcamara, graphites, hepar sulphuris calcareum, hydrocotyle asiatica, kali bromatum, kali iodatum, ledum palustre, lycopdium clavatum, nux vomica, sulphur iodatum, zincum metallicum, silicea. 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.

Acne - Cystic Acne 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.

  • LEDUM PALUSTRE WHOLE 15 [hp_X]/mL
  • SILICON DIOXIDE 15 [hp_X]/mL
  • SULFUR IODIDE 15 [hp_X]/mL
  • LYCOPODIUM CLAVATUM WHOLE 15 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA WHOLE 15 [hp_X]/mL
  • CAUSTICUM 15 [hp_X]/mL
  • CHELIDONIUM MAJUS 15 [hp_X]/mL
  • SOLANUM DULCAMARA WHOLE 15 [hp_X]/mL
  • CALCIUM SULFIDE 15 [hp_X]/mL
  • CENTELLA ASIATICA 15 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 6 [hp_X]/mL
  • JUGLANS REGIA WHOLE 6 [hp_X]/mL
  • GOLD 15 [hp_X]/mL
  • TARAXACUM OFFICINALE 6 [hp_X]/mL
  • ANTIMONY TRISULFIDE 15 [hp_X]/mL
  • BERBERIS AQUIFOLIUM WHOLE 15 [hp_X]/mL
  • CALVATIA GIGANTEA WHOLE 15 [hp_X]/mL
  • POTASSIUM BROMIDE 15 [hp_X]/mL
  • ARCTIUM LAPPA WHOLE 6 [hp_X]/mL
  • ARSENIC TRIOXIDE 15 [hp_X]/mL
  • ACTIVATED CHARCOAL 15 [hp_X]/mL
  • GRAPHITE 15 [hp_X]/mL
  • ZINC 15 [hp_X]/mL
  • POTASSIUM IODIDE 15 [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.

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: 09-02-2019 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.

Acne - Cystic Acne Product Label Images

Acne - Cystic Acne 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

Formulated for symptoms associated with acne such as boils, pimples, pustules, and sebaceous cysts.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times a day or as directed by a health professional.

Otc - Active Ingredient Section

Equal parts of Echinacea 6x, Juglans reg. 6x, Lappa 6x, Taraxacum 6x, Antimon. crud. 15x, Arsenicum alb. 15x, Aur. met. 15x, Berber. aqui. 15x, Bovista 15x, Carbo veg. 15x, Causticum 15x, Chelidonium maj. 15x, Dulcamara 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrocotyle 15x, Kali brom. 15x, Kali iod. 15x, Ledum 15x, Lycopodium 15x, Nux vom. 15x, Silicea 15x, Sulphur iod. 15x, Zinc. met. 15x.

Otc - Purpose Section

Formulated for symptoms associated with acne such as boils, pimples, pustules and sebaceous cysts.

Inactive Ingredient Section

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

Questions Section

Newtonlabs.net - Questions? 800.448.7256Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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.

Otc - Pregnancy Or Breast Feeding Section

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

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.