NDC 59316-879 Biofreeze Portable Dry Solid

Menthol

NDC Product Code 59316-879

NDC 59316-879-22

Package Description: 10 g in 1 CONTAINER

NDC 59316-879-23

Package Description: 1 CONTAINER in 1 CARTON > 10 g in 1 CONTAINER

NDC Product Information

Biofreeze Portable Dry Solid with NDC 59316-879 is a a human over the counter drug product labeled by Performance Health Llc. The generic name of Biofreeze Portable Dry Solid is menthol. The product's dosage form is stick and is administered via topical form.

Labeler Name: Performance Health Llc

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Biofreeze Portable Dry Solid 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 100 mg/g

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.

  • SHEA BUTTER (UNII: K49155WL9Y)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPENTYLDIOL (UNII: 19NOL5474Q)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • 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: Performance Health Llc
Labeler Code: 59316
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: 01-27-2021 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.

Biofreeze Portable Dry Solid Product Label Images

Biofreeze Portable Dry Solid 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 10%

Purpose

Cooling Pain Relief

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • backache • strains • sprains

Warnings:

For external use only

Ask A Doctor Before Use If You Have:

Sensitive skin

When Using This Product:

• Use only as directed • Avoid contact with eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays, or liniments • Do not apply to irritated skin • Wash hands after use with cool water • Do not bandage or use with heating pad or device • Store in a cool dry place away from direct sunlight

Stop Use And Ask A Doctor If:

You experience pain, swelling or blistering; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

If Pregnant Or Breastfeeding:

Ask a health professional before use

Keep Out Of Reach Of Children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions




Adults and Children 12 years of age and older: Turn dial to raise product until a small portion of the stick is showing. Apply by rubbing back and forth to the affected area not more than 4 times daily. Massage not necessary 





Children under 12 years of age: Consult physician

Inactive Ingredients

Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Coco-caprylate/Caprate, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Isopentyldiol, Wax, Paraffin, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Isostearate, Silica, Sodium Chloride, Sorbitan Isostearate, Water

* Please review the disclaimer below.