NDC 43405-102 Eagle Medicated Oil Refreshing

Menthol, Methyl Salicylate

NDC Product Code 43405-102

NDC 43405-102-24

Package Description: 1 BOTTLE, GLASS in 1 BOX > 24 mL in 1 BOTTLE, GLASS

NDC Product Information

Eagle Medicated Oil Refreshing with NDC 43405-102 is a a human over the counter drug product labeled by Borden Company Pte Limited. The generic name of Eagle Medicated Oil Refreshing is menthol, methyl salicylate. The product's dosage form is oil and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2560737.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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 Medicated Oil Refreshing 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)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)

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: 06-30-2021 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".

* Please review the disclaimer below.

Eagle Medicated Oil Refreshing Product Label Images

Eagle Medicated Oil Refreshing 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

Menthol 14%Methyl Salicylate 15%

Purpose

External AnalgesicExternal Analgesic

Uses

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

Warnings

For external use only

When Using This Product

■ avoid getting into the eyes or on mucous membranes■ do not apply to wounds and damaged skin■ do not bandage tightly or use with a heating pad■ do not use otherwise tha as directed

Stop Use And Ask A Doctor If

■ condition worsens, ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ redness is present

Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion contact a doctor or Poison Control Center immediately

Directions

■ adults and children 12 years of age: apply to affected area not more than 3 to 4 times daily. ■ children under 12 years of age, consult a doctor before using

Inactive Ingredients

Clove oil, eucalyptus oil, fragrance, light mineral oil

* Please review the disclaimer below.