NDC 43405-100 Eagle Green Balm

Camphor Menthol

NDC Product Code 43405-100

NDC 43405-100-01

Package Description: 1 JAR in 1 BOX > 20 g in 1 JAR (43405-100-20)

NDC Product Information

Eagle Green Balm with NDC 43405-100 is a a human over the counter drug product labeled by Borden Company Pte Limited. The generic name of Eagle Green Balm is camphor menthol. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2048211.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Eagle Green Balm 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.


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.

  • CLOVE OIL (UNII: 578389D6D0)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • VANILLIN (UNII: CHI530446X)

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.

Product Labeler Information

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

Labeler Name: Borden Company Pte Limited
Labeler Code: 43405
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-14-2018 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: 12-31-2022 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 - NO 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".

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Eagle Green Balm Product Label Images

Eagle Green Balm 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

Active Ingredients

Camphor 11%

Menthol 15%

Purpose

AnalgesicAnalgesic

Indications

For the temporary relief of minor pains and aches of muscles and joints associated with simple backache,arthritis, strains, bruises and sprains

Warning

EXTERNAL USE ONLY■Do not apply towounds and damaged skin■Avoid contact with eyes■Do not bandage tightly■If condition worsens, or if symptoms persist for more than 7 days discontinue use and consult a doctor

Keep Out Of Reach Of Children

■Keep this drug out of reach of children■In case of accidental ingestion seek doctor or Poison Control Center

Directions

For adults and children 2 years of age and older apply to affected area not more than 3 - 4 times daily. Children under 2 years of ageconsult a doctor before use

Other Information

Do not use otherwise than directedKeep in a cool dry place

Inactive Ingredients

Vanillin, Clove Oil, petroleum Jelly, Paraffin Wax

* Please review the disclaimer below.