NDC 55714-2561 Just In Case

Aconitum Napellus, Arnica Montana, Bryonia, Echinacea, Ledum Palustre, Arsenicum Album, Cenchris Contortrix, Crotalus Cascavella, Crotalus Horridus, Lachesis Mutus, Mercurius Corrosivus, Naja Tripudians, Phosphorus, Toxicophis Pugnax, Vipera Berus, Elaps Corallinus, Heloderma.

NDC Product Code 55714-2561

NDC CODE: 55714-2561

Proprietary Name: Just In Case 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 Napellus, Arnica Montana, Bryonia, Echinacea, Ledum Palustre, Arsenicum Album, Cenchris Contortrix, Crotalus Cascavella, Crotalus Horridus, Lachesis Mutus, Mercurius Corrosivus, Naja Tripudians, Phosphorus, Toxicophis Pugnax, Vipera Berus, Elaps Corallinus, Heloderma. 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).

NDC Code Structure

  • 55714 - Newton Laboratories, Inc.

NDC 55714-2561-1

Package Description: 30 mL in 1 BOTTLE, GLASS

NDC Product Information

Just In Case with NDC 55714-2561 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Just In Case is aconitum napellus, arnica montana, bryonia, echinacea, ledum palustre, arsenicum album, cenchris contortrix, crotalus cascavella, crotalus horridus, lachesis mutus, mercurius corrosivus, naja tripudians, phosphorus, toxicophis pugnax, vipera berus, elaps corallinus, heloderma.. 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.

Just In Case 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.

  • BRYONIA ALBA ROOT 10 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 10 [hp_X]/mL
  • RHODODENDRON TOMENTOSUM LEAFY TWIG 10 [hp_X]/mL
  • ARSENIC TRIOXIDE 15 [hp_X]/mL
  • AGKISTRODON CONTORTRIX VENOM 15 [hp_X]/mL
  • CROTALUS DURISSUS TERRIFICUS VENOM 15 [hp_X]/mL
  • CROTALUS HORRIDUS HORRIDUS VENOM 15 [hp_X]/mL
  • ACONITUM NAPELLUS 10 [hp_X]/mL
  • MERCURIC CHLORIDE 15 [hp_X]/mL
  • NAJA NAJA VENOM 15 [hp_X]/mL
  • PHOSPHORUS 15 [hp_X]/mL
  • AGKISTRODON PISCIVORUS VENOM 15 [hp_X]/mL
  • VIPERA BERUS VENOM 15 [hp_X]/mL
  • MICRURUS CORALLINUS VENOM 30 [hp_X]/mL
  • HELODERMA HORRIDUM VENOM 30 [hp_X]/mL
  • ARNICA MONTANA 10 [hp_X]/mL
  • LACHESIS MUTA VENOM 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.
  • 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: 03-02-2020 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: 12-31-2021 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.

Just In Case Product Label Images

Just In Case 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 wilderness injuries, infections and bites such as restlessness, bleeding, trembling, nausea, vomiting, swelling, pain and confusion.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
Warning: For use as an interim therapy. Seek professional medical intervention for severe injuries, bites or infections.

Otc - Active Ingredient Section

Equal parts of Aconitum napellus 10x, Arnica montana 10x, Bryonia 10x, Echinacea 10x, Ledum palustre 10x, Arsenicum album 15x, Cenchris contortrix 15x, Crotalus cascavella 15x, Crotalus horridus 15x, Lachesis mutus 15x, Mercurius corrosivus 15x, Naja tripudians 15x, Phosphorus 15x, Toxicophis pugnax 15x, Vipera berus 15x, Elaps corallinus 30x, Heloderma 30x.

Otc - Purpose Section

Formulated for symptoms associated with wilderness injuries, infections and bites such as restlessness, bleeding, trembling, nausea, vomiting, swelling, pain and confusion.

Inactive Ingredient Section

Inactive Ingredients: 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.