NDC 55714-2232 Eczema - Skin Care

Antimon. Crud., Arsenicum Alb., Berber. Vulg., Bovista, Bryonia, Cantharis, Chelidonium Majus, Croton, Dulcamara, Graphites, Hepar Sulph. Calc., Lycopodium, Mezereum, Nux Vom., Petroleum, Pulex Irritans, Pulsatilla, Rhus Toxicodendron, Sarsaparilla, Sepia, Sulphur Iod., Echinacea, Rumex Crisp., Taraxacum, Urtica Ur.

NDC Product Code 55714-2232

NDC Code: 55714-2232

Proprietary Name: Eczema - Skin 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: Antimon. Crud., Arsenicum Alb., Berber. Vulg., Bovista, Bryonia, Cantharis, Chelidonium Majus, Croton, Dulcamara, Graphites, Hepar Sulph. Calc., Lycopodium, Mezereum, Nux Vom., Petroleum, Pulex Irritans, Pulsatilla, Rhus Toxicodendron, Sarsaparilla, Sepia, Sulphur Iod., Echinacea, Rumex Crisp., Taraxacum, Urtica Ur. 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.
    • 55714-2232 - Eczema - Skin Care

NDC 55714-2232-0

Package Description: .5 mL in 1 BOTTLE, GLASS

NDC 55714-2232-1

Package Description: 29.57 mL in 1 BOTTLE, GLASS

NDC 55714-2232-2

Package Description: 59.14 mL in 1 BOTTLE, GLASS

NDC Product Information

Eczema - Skin Care with NDC 55714-2232 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Eczema - Skin Care is antimon. crud., arsenicum alb., berber. vulg., bovista, bryonia, cantharis, chelidonium majus, croton, dulcamara, graphites, hepar sulph. calc., lycopodium, mezereum, nux vom., petroleum, pulex irritans, pulsatilla, rhus toxicodendron, sarsaparilla, sepia, sulphur iod., echinacea, rumex crisp., taraxacum, urtica ur.. 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.

Eczema - Skin 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.

  • ANTIMONY TRISULFIDE 15 [hp_X]/mL
  • ARSENIC TRIOXIDE 15 [hp_X]/mL
  • BERBERIS VULGARIS ROOT BARK 15 [hp_X]/mL
  • GIANT PUFFBALL 15 [hp_X]/mL
  • BRYONIA ALBA ROOT 15 [hp_X]/mL
  • LYTTA VESICATORIA 15 [hp_X]/mL
  • CHELIDONIUM MAJUS 15 [hp_X]/mL
  • CROTON TIGLIUM SEED 15 [hp_X]/mL
  • SOLANUM DULCAMARA TOP 15 [hp_X]/mL
  • GRAPHITE 15 [hp_X]/mL
  • CALCIUM SULFIDE 15 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 15 [hp_X]/mL
  • DAPHNE MEZEREUM BARK 15 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/mL
  • KEROSENE 15 [hp_X]/mL
  • PULEX IRRITANS 15 [hp_X]/mL
  • PULSATILLA VULGARIS 15 [hp_X]/mL
  • TOXICODENDRON PUBESCENS LEAF 15 [hp_X]/mL
  • SMILAX REGELII ROOT 15 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 15 [hp_X]/mL
  • SULFUR IODIDE 15 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/mL
  • RUMEX CRISPUS ROOT 3 [hp_X]/mL
  • TARAXACUM OFFICINALE 3 [hp_X]/mL
  • URTICA URENS 3 [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.

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: 03-01-2011 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.

Eczema - Skin Care Product Label Images

Eczema - Skin 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

Indications & Usage Section

Eczema - Skin Care   Formulated for symptoms such as inflammation, itching, pain and sensitivity associated with eczema, psoriasis, sunburn, rashes and other skin conditions.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.   Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc - Active Ingredient Section

Antimon. crud. 15x, Arsenicum alb. 15x, Berber. vulg. 15x, Bovista 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Hepar sulph. calc. 15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulex irritans 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sepia 15x, Sulphur iod. 15x, Echinacea 3x, Rumex crisp. 3x, Taraxacum 3x, Urtica ur. 3x.

Otc - Purpose Section

Formulated for symptoms such as inflammation, itching, pain and sensitivity associated with eczema, psoriasis, sunburn, rashes and other skin conditions.

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.

Otc - 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.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.

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