NDC 22431-289 Pain Freeze Roll-on Cold Therapy Pain Relief


NDC Product Code 22431-289

NDC CODE: 22431-289

Proprietary Name: Pain Freeze Roll-on Cold Therapy Pain Relief 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: 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

  • 22431 - Blue Cross Laboratories, Inc
    • 22431-289 - Pain Freeze Roll-on Cold Therapy Pain Relief

NDC 22431-289-01

Package Description: 89 mL in 1 BOTTLE

NDC Product Information

Pain Freeze Roll-on Cold Therapy Pain Relief with NDC 22431-289 is a a human over the counter drug product labeled by Blue Cross Laboratories, Inc. The generic name of Pain Freeze Roll-on Cold Therapy Pain Relief is menthol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Blue Cross Laboratories, Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Pain Freeze Roll-on Cold Therapy Pain Relief 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.

  • MENTHOL 6 g/100mL

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.

  • CAMPHOR, (-)- (UNII: 213N3S8275)
  • CARBOMER 934 (UNII: Z135WT9208)
  • WATER (UNII: 059QF0KO0R)

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: Blue Cross Laboratories, Inc
Labeler Code: 22431
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: 09-06-2019 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: 12-31-2020 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.

Pain Freeze Roll-on Cold Therapy Pain Relief Product Label Images

Pain Freeze Roll-on Cold Therapy Pain Relief 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 Ingredient PurposeMenthol 6% Topical analgesic

Otc - Purpose

Uses: Provides soothing cold to sore muscles and joints

Otc - Keep Out Of Reach Of Children

Keep out of reach of children: In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for childen 5 years or younger.

Indications & Usage

Ask a doctor before using before use if pregnant or breast feeding. Consult a doctor and discontinue use if irritation occurs.


Warnings:For external use only. Avoid contact with eyes, mucous membranes or broken skin.When using this product, do not: heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucous membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.
Do not use other than as directed.

Dosage & Administration

Directions: Apply liberally to area of pain and massage until lotion is absorbed into the skin

Inactive Ingredient

Inactive Ingredients: Water, Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf Extract, Calendula Officinalis Extract, Arctium Lappa (Burdock) Root Extract, Ilex Paragariensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis (Green Tea) Leaf Extract, Melissa Officinalis (Lemon Balm) Leaf Extract, Camphor, Isopropyl Myristate, Carbomer, Triethanolamine, Silicon Dioxide, Tocopheryl (Vitamin E) Acetate.

* Please review the disclaimer below.