NDC 69542-555 Kay Medic Menthol Pain Relief

Menthol

NDC Product Code 69542-555

NDC 69542-555-01

Package Description: 29.5 mL in 1 JAR

NDC Product Information

Kay Medic Menthol Pain Relief with NDC 69542-555 is a 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.

Labeler Name: Kay Medic Llc

Dosage Form: Cream - 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.

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.

Kay Medic Menthol Pain Relief 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 30 mg/mL

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.

  • ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
  • ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
  • WATER (UNII: 059QF0KO0R)
  • ARISAEMA ERUBESCENS ROOT (UNII: 3E8P1PU8SY)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • FRANKINCENSE (UNII: R9XLF1R1WM)
  • ATLANTIC ROCK CRAB (UNII: 2K19902G3Q)
  • CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
  • BLACK COHOSH (UNII: K73E24S6X9)
  • MYRRH (UNII: JC71GJ1F3L)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • MAMMAL BONE, FOSSILIZED (UNII: 0N1T3913DA)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • LIGUSTICUM WALLICHII ROOT (UNII: R81AD159QS)
  • DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
  • NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • STRYCHNOS NUX-VOMICA WHOLE (UNII: AB2NX17POS)

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: Kay Medic Llc
Labeler Code: 69542
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: 01-21-2015 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.

Kay Medic Menthol Pain Relief Product Label Images

Kay Medic Menthol Pain Relief 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 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 MEDICMENTHOL PAIN RELIEF CREAM1oz. (29.5735mL)Manufactured for Kay Medic LLC, Davie, Florida, 33331 USAQuestions or comments? Call 1-888-217-8628 (English)

* Please review the disclaimer below.