NDC 63936-9505 Stopain Clinical

Menthol

NDC Product Code 63936-9505

NDC 63936-9505-5

Package Description: 50 mL in 1 BOTTLE, PUMP

NDC Product Information

Stopain Clinical with NDC 63936-9505 is a a human over the counter drug product labeled by Troy Manufacturing, Inc.. The generic name of Stopain Clinical is menthol. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 259249.

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.

Stopain Clinical 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.

  • ACRYLIC ACID (UNII: J94PBK7X8S)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • 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: Troy Manufacturing, Inc.
Labeler Code: 63936
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: 08-09-2021 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 - 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.

Stopain Clinical Product Label Images

Stopain Clinical 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 Ingredient

Menthol 10.0%

Purpose

Topical Analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with:simple backachearthritisstrainsbruisessprains

Warnings

For external use only. Avoid contact with eyes.


Flammable: Keep away from fire or flame.

When Using This Product

  • Use only as directeddo not bandage tightly or use a heating paddo not apply to wounds or damaged skin

Stop Use And Ask A Doctor If

  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few daysredness is presentexcessive irritation of the skin develops

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 over 12 years:apply directly onto affected area without the need to bandagerepeat if necessary, but do not apply more than 4 times daily.Children 12 years or younger: ask a doctor.

Other Information

  • Store at room temperature

Inactive Ingredients

Acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, triethanolamine, water (USP).

* Please review the disclaimer below.