NDC 76277-212 Injurease

Arnica Montana, Ledum Palustre, Rhus Toxicodendron, Ruta Graveolens

NDC Product Code 76277-212

NDC 76277-212-11

Package Description: 15 g in 1 POUCH

NDC Product Information

Injurease with NDC 76277-212 is a a human over the counter drug product labeled by Cearna, Inc.. The generic name of Injurease is arnica montana, ledum palustre, rhus toxicodendron, ruta graveolens. The product's dosage form is gel and is administered via topical form.

Labeler Name: Cearna, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Injurease 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.

  • ARNICA MONTANA 50 [hp_M]/g
  • TOXICODENDRON PUBESCENS LEAF 50 [hp_M]/g
  • RUTA GRAVEOLENS FLOWERING TOP 50 [hp_M]/g
  • LEDUM PALUSTRE TWIG 50 [hp_M]/g

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.

  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • WATER (UNII: 059QF0KO0R)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • METHYL DIETHANOLAMINE (UNII: 3IG3K131QJ)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Cearna, Inc.
Labeler Code: 76277
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: 05-26-2020 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.

Injurease Product Label Images

Injurease 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 - Active Ingredient

Active Ingredients for Healing Gels: Arnica Montana 50MLedum Palustre 50MRhus toxicodendron 50MRuta graveolens 50M

Otc - Purpose

Purpose: Arnica Montana 50M...........................Bruising, muscle strain Ledum Palustre 50M.........................................Swelling, pain Rhus toxicodendron 50M........Sprains, strains, swelling, pain Ruta graveolens 50M..........................Tendonitis, shin splints

Indications & Usage

For the reduction of swelling and pain associated with: joint sprains, muscle and ligament strains, tendonitis, shin splints, dislocations, overuse injuries, and plantar fasciitis.

Warnings

  • WarningsFor external use on intact skin onlyDo not use in the eyes, over open wounds, or if you have unexpected bleedingStop use and ask a doctor if condition worsensIf pregnant or breast-feeding, ask a health professional before use.

Otc - Do Not Use

Do not use:Do not use in the eyes, over open wounds, or if you have unexpected bleeding

Stop Use And Ask A Doctor

​Stop use and ask a doctor if condition worsens

Otc - Pregnancy Or Breast Feeding

I
f pregnant or breast-feeding ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Directions:Place healing pads on intact skin, and replace as needed

Storage And Handling

Other informationStore at room temperature.

Inactive Ingredient

Acrylates/Acrylamide Co-polymer, Hydroxyethyl Cellulose, Methyldiethanolamine, Water

Questions

Questions: 1-630-740-4580
or Email info1@cearna.com

Description

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.Do not use if pouches are open.

* Please review the disclaimer below.