NDC 72602-002 Mentho Patch Cool

Menthol

NDC Product Code 72602-002

NDC 72602-002-01

Package Description: 10 g in 1 PATCH

NDC Product Information

Mentho Patch Cool with NDC 72602-002 is a a human over the counter drug product labeled by The Egyptian Saudi Co For Medical Manufacturing Mascomid. The generic name of Mentho Patch Cool is menthol. The product's dosage form is patch and is administered via topical form.

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.

Mentho Patch Cool 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • ALUMINUM CHLORIDE ANHYDROUS (UNII: LIF1N9568Y)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • TARTARIC ACID (UNII: W4888I119H)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • CARBOXYMETHYLCELLULOSE SODIUM (0.9 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 600 MPA.S AT 2%) (UNII: ZY4732LP1O)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)

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: The Egyptian Saudi Co For Medical Manufacturing Mascomid
Labeler Code: 72602
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: 09-20-2018 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: 12-31-2022 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.

Mentho Patch Cool 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

Purpose

For the temprorary releif of minor aches and pains of musceles and joints associated with simple backache, arthritis,strainsand sprains

Warnings

  • FOR EXTERNAL USE ONLYWhen Using this ProductAvoid contact with eyesDo not apply to open wounds, or to damaged skinDo not bandage tightly.

Directions

  • Adults and children 3 years of age and older: apply to affected area not more than 3 to 4 times daily.Children under 3 years of age: consult doctor.

Stop Use And Ask Doctor

  • If condition worsensIf symptoms persist more than 7 days or clear up and occur again with a few days

Storage

  • Store in cool dry place avoid direct sunlight.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Active Ingridient Section

Menthol,Camphor,Methyl salicylate

Inactive Ingredient Section

Glycerin ,Sodium poly acryl ate ,Aluminum chloride hex hydrate 2 ,Anhydrous citric acid ,Tartaric acid 1 ,Poly sorbate -80 (tween 80) 0.5 ,Isopropyl myristate alcohol 2.5 ,Car boxy methyl cellulose (CMC) 2 EDETA 0.5 ,Polyvinyl pyrolidone(PVP-K90) 3 ,Water 48.35 ,titanium dioxide 0.05,ACRYLATE/ C10-30 ALKYL ACRYLATE,cross polymer

* Please review the disclaimer below.