NDC 55714-2380 Accident - Injury Rescue
Aconitum Nap, Arnica, Bellis, Calendula, Echinacea, Gelsemium, Hamamelis, Hypericum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis Canadensis. Liquid Oral

Product Information

Product Code55714-2380
Proprietary Name 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.
Accident - Injury Rescue
Non-Proprietary Name 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.
Aconitum Nap, Arnica, Bellis, Calendula, Echinacea, Gelsemium, Hamamelis, Hypericum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis Canadensis.
Product Type 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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Newton Laboratories, Inc.
Labeler Code55714
Marketing Category 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.
UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-17-2018
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Packages

NDC 55714-2380-1

Package Description: 30 mL in 1 BOTTLE, GLASS

Product Details

Accident - Injury Rescue is a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Accident - Injury Rescue is aconitum nap, arnica, bellis, calendula, echinacea, gelsemium, hamamelis, hypericum, ledum, phosphorus, rhus toxicodendron, ruta, staphysag., symphytum, hydrastis canadensis.. The product's dosage form is liquid and is administered via oral form.


What are Accident - Injury Rescue Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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)


* Please review the disclaimer below.

Accident - Injury Rescue Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Inactive Ingredient Section



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


Questions



newtonlabs.net ~ Questions? 800-448-7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013


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.


Otc - Purpose Section



Formulated for symptoms associated with trauma or medical procedures such as pain, emotional upset, bruising and inflammation.


Warnings Section



Warning: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.


Otc - Active Ingredient Section



Equal parts of Echinacea 6x, Hydrastis 6x, Hypericum 6x, Symphytum 6x, Aconitum nap. 15x, Arnica 15x, Bellis 15x, Calendula 15x, Echinacea 15x, Gelsemium 15x, Hamamelis 15x, Hypericum 15x, Ledum 15x, Phos. 15x, Rhus tox. 15x, Ruta 15x, Staphysag. 15x, Symphytum 15x,


Indications & Usage Section



Accident - Injury Rescue Formulated for symptoms associated with trauma or medical procedures such as pain, emotional upset, bruising and inflammation.


Package Label




* Please review the disclaimer below.