NDC 69889-026 Mtx Topical Pain

Lidocaine Hydrochloride, Menthol

NDC Product Code 69889-026

NDC 69889-026-15

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

NDC Product Information

Mtx Topical Pain with NDC 69889-026 is a a human over the counter drug product labeled by Unik Pharmaceuticals, Inc.. The generic name of Mtx Topical Pain is lidocaine hydrochloride, menthol. 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: 1373130.

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.

Mtx 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • 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: 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.

Mtx Topical Pain Product Label Images

Mtx 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:

Lidocaine HCl 4.00%Menthol 1.00%

Uses:

For temporary relief of pain and itching associated with minor burns, cuts, scrapes and minor skin irritations.

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 other external analgesic products..• Do not use with any bandage, wrap, stocking or similar device or garment.• If symptoms persist for more than 7 days, discontinue use and consult a physician.

Keep Out Of Reach Of Children.

• Children under 12 should consult physician prior to use.





• If swallowed, consult a physician





• Do not bandage tightly.

Stop Use And Consult Physician

• if symptoms worsen or persist for more than 7 days.

If Pregnant Or Breast Feeding,

• contact physician prior to use.

Directions:







Adults and children 12-years and over: Apply to affected area.











Children under 12: consult a physician before use.











How to Apply:• Clean and dry affected area.





• Remove patch from backing and apply directly to affected area.





• Use only one patch at a time, and maximum of four patches per day.





• Leave patch on affected area for up to 8-hours.





• Do not use patches for longer than five consecutive days.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5.

Store At Room Temperature.

  • Avoid direct sunlight

* Please review the disclaimer below.