NDC 65923-205 Coralite Cold And Hot

Menthol

NDC Product Code 65923-205

NDC 65923-205-02

Package Description: 2 PATCH in 1 POUCH > 1 PATCH in 1 PATCH

NDC Product Information

Coralite Cold And Hot with NDC 65923-205 is a a human over the counter drug product labeled by United Exchange Corp.. The generic name of Coralite Cold And Hot is menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: United Exchange Corp.

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.


Coralite Cold And Hot 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 5 mg/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.

  • TARTARIC ACID (UNII: W4888I119H)
  • DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
  • KAOLIN (UNII: 24H4NWX5CO)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: United Exchange Corp.
Labeler Code: 65923
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.

Coralite Cold And Hot Product Label Images

Coralite Cold And Hot 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 - Active Ingredient

Drug FactsActive ingredient PurposeMenthol 5%......................................................Topical analgesic

Otc - Purpose

  • Usestemporarily relieves minor aches and pains of muscles and joints associated with:simple backachearthritisstrains bruisessprains

Warnings

WarningsFor external use only

Otc - Do Not Use

  • Do not useon wounds or damaged skinwith a heating padon a child under 12 years of age with arthritis-like conditions

Otc - Ask Doctor

  • Ask a doctor before use if you haveredness over the affected area

Otc - When Using

  • When using this productuse only as directedavoid contact with eyes or mucous membranesdo not bandage tightlydiscontinue use at least 1 hour before a bath or showerdo not use immediately after a bath or shower

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsens or symptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysexcessive skin irritation occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Indications & Usage

  • Directionsopen pouch and remove patchcarefully peel off protective backing and apply sticky side to affected areaadults and children 12 years of age and older:do not wear patch for more than 8 hoursapply to affected area no more than 3 times dailychildren under 12 years of age: consult a doctor

Storage And Handling

  • Other informationstore at room temperature 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredientsalcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

Dosage & Administration

Distributed by:United Exchange Corp.Cypress, CA 90630 USAMade in China

* Please review the disclaimer below.

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