NDC 65923-705 Hot And Cold

Menthol

NDC Product Code 65923-705

NDC 65923-705-05

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

NDC Product Information

Hot And Cold with NDC 65923-705 is a a human over the counter drug product labeled by United Exchange Corp. The generic name of Hot And Cold 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.

Hot And Cold 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 750 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SORBITOL (UNII: 506T60A25R)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • GELATIN (UNII: 2G86QN327L)
  • KAOLIN (UNII: 24H4NWX5CO)
  • MAGALDRATE (UNII: 6V88E24N5T)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
  • TARTARIC ACID (UNII: W4888I119H)

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.
  • 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: 08-28-2020 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 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.

Hot And Cold Product Label Images

Hot And Cold 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

Active ingredient PurposeMenthol 5%................................................................................Topical analgesic

Otc - Purpose

  • Uses Temporarily relieves minor pain associated with:arthritissimple backachebursitistendonitismuscle strainsmuscle sprainsbruisescramps

Warnings

Warnings For external use only.

Otc - When Using

  • When using this productuse only as directeddo not bandage tightly or use with a heating padavoid contact with eyes and mucous membranesdo not apply to wounds or damaged skin

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 days or clear up and occur again within a few daysredness is presentskin irritation develops

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Pregnancy Or Breast Feeding

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

Indications & Usage

  • Directionsadults and children over 12 years:carefully peel off protective backingapply sticky side to affected areawear one patch up to 8 hoursrepeat as necessary but no more than 3 times dailychildren 12 years or younger:consult a doctor

Storage And Handling

  • Other informationstore at room temperature, not to exceed 86°F (30°C)

Inactive Ingredient

Inactive ingredients 1,3-butylene glycol, aloe vera, BHT, d-sorbitol, disodium edetate, gelatin, glycerine, kaolin, liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

Dosage & Administration

Distributed By:United Exchange Corp5836 Corporate Ave.Cypress CA 90630Made in Korea

* Please review the disclaimer below.