NDC 62168-0086 Dorflex Icy Hot Flexible, Large

Menthol

NDC Product Code 62168-0086

NDC 62168-0086-5

Package Description: 100 POUCH in 1 BOX > 5 PATCH in 1 POUCH

NDC 62168-0086-6

Package Description: 100 POUCH in 1 BOX > 5 PATCH in 1 POUCH

NDC Product Information

Dorflex Icy Hot Flexible, Large with NDC 62168-0086 is a a human over the counter drug product labeled by Lead Chemical Co. Ltd.. The generic name of Dorflex Icy Hot Flexible, Large is menthol. The product's dosage form is patch and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1432289 and 420222.

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.

Dorflex Icy Hot Flexible, Large 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)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • METHYL ACRYLATE (UNII: WC487PR91H)
  • NONOXYNOL-30 (UNII: JJX07DG188)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TALC (UNII: 7SEV7J4R1U)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • ACRYLIC ACID (UNII: J94PBK7X8S)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • METHYL ACRYLATE (UNII: WC487PR91H)
  • NONOXYNOL-30 (UNII: JJX07DG188)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TALC (UNII: 7SEV7J4R1U)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • 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: Lead Chemical Co. Ltd.
Labeler Code: 62168
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: 07-01-2013 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.

Dorflex Icy Hot Flexible, Large 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%

Purpose

Topical analgesic

Uses

Dorflex Icy Hot is indicated for bruises, traumas, muscle pains, cramps, torticollis and painful and inflammatory processes at large.

Warnings

For external use onlyFor use in adults and children over 12 years.

When Using This Product

  • Use only as directed.Do not use with a heating pad.Avoid contact with eyes and mucous membranes.Do not apply to wounds or damaged, broken or irritated skin.

Stop Use And Ask A Doctor If

  • Condition worsens.Irritation or redness develops.Symptoms persist for more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast-Feeding,

Ask a doctor before use.

Keep Out Of Reach Of Children.

If swallowed by accident, get medical help.

Directions

  • Remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middleCarefully remove smaller portion of backing from patch and apply exposed portion of patch to affected areaOnce exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected areaChildren 12 years or younger, ask a doctor

Precautions

  • Do not wear the same patch for more than 8 hours.Do not wear more than 3 patches daily.Store in ambient temperature.Use each patch only once.

Inactive Ingredients

Acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water

Other Information

Responsible pharmacist: Antonia A. Oliveira - CRF-SP 5.854. MS 8013490015Manufactured by: Lead Chemical Company, Ltd., 77-3 Himata, Toyama City, 930-0912. Toyama, Japan. Packaged by: Chattem, Inc., 1715 West 38th Street, Chattanooga, Tennessee, 37409. United States. Imported by: Sanofi-Aventis Farmaceutica Ltda. Rua Conde domingos Papais, 413 - Suzano - SP - CEP 08613-010. CNPJ 02.685.377/0008-23.

* Please review the disclaimer below.