NDC 69876-1740 Neuroflex Topical Pain Relieving Liquid

Camphor (synthetic), Menthol

NDC Product Code 69876-1740

NDC CODE: 69876-1740

Proprietary Name: Neuroflex Topical Pain Relieving Liquid 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: Camphor (synthetic), Menthol 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.

NDC Code Structure

  • 69876 - Almark Products Inc
    • 69876-1740 - Neuroflex Topical Pain Relieving Liquid

NDC 69876-1740-0

Package Description: 118 mL in 1 BOTTLE, SPRAY

NDC Product Information

Neuroflex Topical Pain Relieving Liquid with NDC 69876-1740 is a a human over the counter drug product labeled by Almark Products Inc. The generic name of Neuroflex Topical Pain Relieving Liquid is camphor (synthetic), menthol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Almark Products Inc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Neuroflex Topical Pain Relieving Liquid 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.

  • CAMPHOR (SYNTHETIC) 30 mg/mL
  • MENTHOL 20 mg/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.

  • EUCALYPTUS GUM (UNII: 72T9EZC2VX)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)

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: Almark Products Inc
Labeler Code: 69876
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: 04-01-2021 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.

Neuroflex Topical Pain Relieving Liquid Product Label Images

Neuroflex Topical Pain Relieving Liquid 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 3.00%


Menthol 2.00%

Purpose

Pain Reliever

Uses

For temporary relief of minor aches and pains of muscles and joints:


• arthritis • simple backaches • soreness • strains • sprains • bruises

Warnings

For External Use OnlyFlammable: Keep away from fire or flame.

Do Not Use

• on wounds • on damaged skin • on mucous membranes

When Using This Product

• avoid contact with eyes • do not bandage tightly • do not use a heating pad

Stop Use And Ask A Doctor If

• condition worsens • symptoms persist for more than 7 days • symptoms clear up and occur again within a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 2 years of age and older. Apply to affected areas not more than 3 to 4 times daily. No need to rub in.


• Children under 2 years of age: Consult a physician.

Inactive Ingredients

Eucalyptus Globulus Lead (Eucaluptus) Oil, Melaleuca, Alternifolia (australian Tea Tree) Leaf Oil, Pinus Sylvestris (Pine) Oil, Polysorbate-20, SD-Alcohol 40B.

* Please review the disclaimer below.