NDC 69889-027 Cmx Topical Pain

Menthol, Capsaicin

NDC Product Code 69889-027

NDC 69889-027-15

Package Description: 15 PACKAGE in 1 BOX > 8 g in 1 PACKAGE

NDC Product Information

Cmx Topical Pain with NDC 69889-027 is a a human over the counter drug product labeled by Unik Pharmaceuticals, Inc. The generic name of Cmx Topical Pain is menthol, capsaicin. The product's dosage form is patch and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1300889.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Cmx Topical Pain 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Unik Pharmaceuticals, Inc
Labeler Code: 69889
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: 09-15-2016 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: 12-31-2021 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.

Cmx Topical Pain Product Label Images

Cmx Topical Pain 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 5.00%Capsaicin 0.0375%

Uses:

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

Warnings:

• For external use only. Use only as directed.





• Avoid contact with eyes and mucous membranes.





• Do not apply to open wounds or damaged skin.

Do Not Use

• in combination with any external heat source.





• Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar





device or garment.

Keep Out Of Reach Of Children.

• Consult physician for children under 12.





• Do not use if allergic to Menthol.

Stop Use And Consult Physician

• if symptoms worsen or persist for more than 7 days.• Stop use if itching to excessive skin irritation occurs.

If Pregnant Or Breast Feeding

• contact physician prior to use.

Directions:







Adults and children 12-years and over: Apply to affected area; change patch 1-2 times daily.











Children under 12, consult a physician before use.











How to Apply:• Clean and dry affected area.





• Remove patch from backing and apply directly to area of pain.





• Do not apply to affected area more than three times daily.





• Use only on patch at a time.





• Wash hands with soap and water immediately after application.





• Reseal pouch containing unused patches.

Other Ingredients:

Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Polysorbate-80, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodium Salt, Diazolidinyl Urea, Methyl Paraben, Iodopropynyl Butylcarbamate, Propyl Paraben.

Store At Room Temperature.

Avoid direct sunlight

* Please review the disclaimer below.