NDC 69542-555 Kay Medic Menthol Pain Relief
Menthol Cream Topical

Product Information

What is NDC 69542-555?

The NDC code 69542-555 is assigned by the FDA to the product Kay Medic Menthol Pain Relief which is a human over the counter drug product labeled by Kay Medic Llc. The generic name of Kay Medic Menthol Pain Relief is menthol. The product's dosage form is cream and is administered via topical form. The product is distributed in a single package with assigned NDC code 69542-555-01 29.5 ml in 1 jar . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code69542-555
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Kay Medic Menthol Pain Relief
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Menthol
Product Type 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.
Human Otc Drug
Dosage FormCream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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.
Kay Medic Llc
Labeler Code69542
FDA Application Number 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.
part348
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-21-2015
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Kay Medic Menthol Pain Relief?


Product Packages

NDC Code 69542-555-01

Package Description: 29.5 mL in 1 JAR

Product Details

What are Kay Medic Menthol Pain Relief Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Kay Medic Menthol Pain Relief Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Kay Medic Menthol Pain Relief Inactive Ingredients UNII Codes

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.

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Kay Medic Menthol Pain Relief Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients



Menthol             3.00%


Purpose



External Analgesic


Uses



for the temporary relief of minor aches, and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.


Warnings



  • For external use only. Avoid contact with eyes, nose, mouth and genitalia.
  • Use only as directed.
  • Do not apply to open wounds or damaged skin.
  • Do no bandage tightly

Otc - Ask Doctor



Ask a doctor before use if you have sensitive skin.


Keep Out Of Reach Of Children.



If swallowed, contact your local poision control center or emergency room immediately.


Otc - Stop Use



If symptoms persist for more than seven days, discontinue use and consult physician.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast feeding, contact physcian prior to use.


Directions:



Adults and children 12 years  of age or older: apply to affected area not more than 3 or 4  times daily.

Children under 12 years of age: ask a doctor before use.


Other Ingredients



Acorus Calamus (Sweet Flag/Shi Chang Pu) Rhizome Extract,Aloe Barbadensis Leaf Extract (Aloe Vera Gel), Angelica Dahurica Root Extract, Angelica Sinensis Root Tip Extract, Aqua (Deionized Water), Arisaema(Jack-In The-Pulpit) Rhizome Processed With Bovine Bile (Bile Arisaema/Dan Nan Xing) Extract; Bis-Vinyl Dimethicone/Dimethicone Copolymer; Boswellia Sacra (Frankincense/Olivanum) Resin; Cancer Irroratus (Atlantic Rock Crab) Carapace Extract; Carthamus Tinctorius (Safflower) Extract; Cetyl Alcohol; Chondroitin Sulfate; Cimicifuga Racemosa (Climicifuga) Root Extract; Commiphora Myrrha Resin Extract;Cyclopentasiloxane; Dracaena Cinnabari (Dragon's Blood) Resin Extract;Fossilized Mammals Bones ("Dragon" Bones/Long Gu) Extract; Glucosamine Sulfate; Glycerin; Glyceryl Stearate, Ledebouriella Divaricata (Ledebouriella/Fang Feng) Root Extract; Ligusticum Wallichii (Szechuan Lovage/Chuanxiong) Root Extract; Methylsulfinylmethane (Msm); Notopterygium Incisum (Notopterygium) Root Extract; Peg-100 Stearate; Peg-12 Dimethicone; Phenoxyethanol; Polysorbate-20; Propylene Glycol; Stearic Acid; Strychnos Nux-Vomica (Strychnine Tree/Yanhusuo) Extract.


Pakage Labeling



KAY MEDIC

MENTHOL PAIN RELIEF CREAM

1oz. (29.5735mL)

Manufactured for Kay Medic LLC, Davie, Florida, 33331 USA

Questions or comments? Call 1-888-217-8628 (English)


* Please review the disclaimer below.