NDC 66902-292 Cvs Health Pain Relief Foot

Menthol, Unspecified Form

NDC Product Code 66902-292

NDC 66902-292-04

Package Description: 113 g in 1 TUBE

NDC Product Information

Cvs Health Pain Relief Foot with NDC 66902-292 is a a human over the counter drug product labeled by Natural Essentials, Inc.. The generic name of Cvs Health Pain Relief Foot is menthol, unspecified form. The product's dosage form is cream and is administered via topical form.

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.

Cvs Health Pain Relief Foot 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.

  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • WATER (UNII: 059QF0KO0R)

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: Natural Essentials, Inc.
Labeler Code: 66902
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: 10-22-2021 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.

Cvs Health Pain Relief Foot Product Label Images

Cvs Health Pain Relief Foot 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 Ingredient

Menthol 10%

Purpose

Topical Analgesic

Uses:

  • Temporary relief from minor aches and pains of sore muscles and joints associated with:
  • Arthritis
  • Backache
  • Strains
  • Sprains

Warnings:

For external use only

Otc - Ask Doctor

Ask a doctor before use if you have: Sensitive skin
Flammable: Keep away from excessive heat or open flame.

When Using This Product:

  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device
  • Store in a cool dry place, away from sunlight

Stop Use And Ask A Doctor If:

  • Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

If Pregnant Or Breastfeeding:

Ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children and pets: If accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions:

  • Adults and Children 12 years of age and older:Rub a thin film over affected areas not more than 4 times daily; massage not necessary
  • Children under 12 years of age: Consult physician

Inactive Ingredients:

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Gluconolactone, Glycerin, Glyceryl Stearate, Ilex Paraguarensis Leaf Extract, Phenoxyethanol, Polysorbate 60, Sodium Hydroxide, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Oil, Water.

* Please review the disclaimer below.