NDC 59316-115 Biofreeze Professional

Menthol, Unspecified Form

NDC Product Code 59316-115

NDC 59316-115-11

Package Description: 3 mL in 1 PACKET

NDC 59316-115-20

Package Description: 118 mL in 1 TUBE

NDC 59316-115-30

Package Description: 473 mL in 1 BOTTLE

NDC 59316-115-40

Package Description: 946 mL in 1 BOTTLE

NDC 59316-115-50

Package Description: 3785 mL in 1 BOTTLE

NDC 59316-115-82

Package Description: 100 PACKET in 1 CARTON > 3 mL in 1 PACKET

NDC Product Information

Biofreeze Professional with NDC 59316-115 is a a human over the counter drug product labeled by Performance Health, Llc. The generic name of Biofreeze Professional is menthol, unspecified form. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1794892 and 415975.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Professional 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FRANKINCENSE (UNII: R9XLF1R1WM)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: 06-03-2016 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.

Biofreeze Professional Product Label Images

Biofreeze Professional 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 USP 5%

Purpose

Cooling Pain Relief

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with arthiritis, backache, strains and sprains

Warnings:

For external use onlyFlammable: Keep away from excessive heat or open flame

Ask A Doctor Before Use If You Have:

Sensitive skin

When Using This Product:

Avoid contact with the eyes or mucous membranes; Do not apply to wounds or damaged skin; Do not use with other ointments, creams, sprays or liniment; Do not apply to irritated skin or if excessive irritation develops; Do not bandage; Wash hands after use with cool water; Do not use with heating pad or device; Store in cool dry place

Stop Use And Ask A Doctor If:

Condition worsens, or if symptoms persist for more than 7 days , or clear up and recur

If Pregnant Or Breast-Feeding:

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 2 years of age and older: Rub a thin film over affected areas not more four times daily; massage not necessary


Children under 2 years of age: Consult physician

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5

* Please review the disclaimer below.