NDC 55758-316 Flexsport Roll On

Menthol

NDC Product Code 55758-316

NDC 55758-316-02

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 BOX > 1 CREAM in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Flexsport Roll On with NDC 55758-316 is a a human over the counter drug product labeled by Pharmadel Llc. The generic name of Flexsport Roll On is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Pharmadel Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.


Flexsport Roll On 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 16 g/1

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.

  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • DIHYDROCAPSAICIN (UNII: W9BV32M08A)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

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: Pharmadel Llc
Labeler Code: 55758
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: 04-04-2019 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.

Flexsport Roll On Product Label Images

Flexsport Roll On 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 - Purpose

Active ingredientPurposeMenthol 16% ....................Topical analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with:arthritissimple backachemuscle strainssprainsbruises

Warnings

For external use only. Avoid contact with the eyes.Flammable: keep away from fire or flame.

When Using This Product

  • Do not bandage tightly or use with a heating paddo not apply to wounds or damaged, broken or irritated skin

Stop Use And Ask A Doctor If

  • Condition worsensredness is presentirritation developssymptoms persist for more than 7 days or clear up and occur again within a few days

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

  • Use only as directedadults and children over 12 years:apply generously to affected areamassage into painful area until thoroughly absorbed into skinrepeat as necessary, but no more than 3 to 4 times dailyif product comes in contact with hands, wash with soap and water immediatelydo not expose the area treated with product to heat or direct sunlightChildren 12 years of age and under: ask a doctor

Other Information

  • Store at temperatures not exceeding 15°–30°C(59°– 86°F)avoid excessive heat and humidityDo not use if clear shrink seal over cap is broken, torn or missing.save box for complete drug facts

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, capsaicin, glycerin, isopropyl myristate, propylene glycol, trolamine, water

* Please review the disclaimer below.

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