NDC 41167-0090 Icy Hot Original Foam

Menthol

NDC Product Code 41167-0090

NDC 41167-0090-1

Package Description: 118 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Icy Hot Original Foam with NDC 41167-0090 is a a human over the counter drug product labeled by Chattem, Inc.. The generic name of Icy Hot Original Foam is menthol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Chattem, 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.

Icy Hot Original Foam 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 140.8 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.

  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALCOHOL (UNII: 3K9958V90M)
  • BIS-PEG-12 DIMETHICONE (500 MPA.S) (UNII: 2CNS542YRT)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)

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: Chattem, Inc.
Labeler Code: 41167
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: 01-15-2021 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 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.

Icy Hot Original Foam Product Label Images

Icy Hot Original Foam 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

Purpose

Menthol 16%......................................................................................................................................Topical analgesic

Uses

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

Warnings

For external use only    Flammable ■ keep away from heat and open flame

Do Not Use

■ on wounds, damaged, broken or irritated skin■ with a heating pad

When Using This Product

■ use only as directed■ do not bandage tightly■ do not expose the area to local heat or to direct sunlight■ rare cases of serious burns have been reported with products of this type■ a transient burning sensation may occur upon application but generally disappears in several days■ avoid contact with the eyes and mucous membranes

Stop Use And Ask A Doctor If

■ condition worsens or symptoms persist for more than 7 days■ symptoms clear up and occur again within a few days■ severe burning sensation, redness or irritation develop■ experience signs of skin injury, such as pain, swelling or blistering where the product was applied

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

Adults and children 12 years of age and older:■ pump slowly and apply to the affected area not more than 3 to 4 times daily■ wash hands thoroughly with soap and water after each usechildren under 12 years of age:  consult a doctor

Inactive Ingredients

Alcohol denat. (50%), bis-PEG-8 dimethicone, bis-PEG-12 dimethicone, propylene glycol, water

* Please review the disclaimer below.