NDC 59779-672 Warming Epsom Rub

Menthol

NDC Product Code 59779-672

NDC 59779-672-43

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Warming Epsom Rub with NDC 59779-672 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Warming Epsom Rub is menthol. The product's dosage form is granule, for solution and is administered via topical form.

Labeler Name: Cvs Pharmacy

Dosage Form: Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.

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.

Warming Epsom Rub 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 11.7 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.

  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • CAPSICUM (UNII: 00UK7646FG)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)

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: Cvs Pharmacy
Labeler Code: 59779
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: 05-05-2015 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: 12-31-2022 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.

Warming Epsom Rub Product Label Images

Warming Epsom Rub 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

Purpose

Topical Analgesic

Use

For the temporry relief of minor aches and pains of muscle joints associated with simple backache, arthritis, strains, bruises, and sprains

Warnings

For external use only

Flammable

  • Keep away from fire or flame, heat, spark, electrical

When Using This Product

  • Avoid contact with the eyesdo not apply to wounds or damaged skindo not bandage tightly

Stop Use And Ask A Doctor If

Condition worsens, or if symptoms persist for more then 7 days or clar up and occur again within a few days

Keep Out Of Reach Of Children

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

Directions

Adults and children 2 years of age and older  - apply to affected area not more than 3 to 4 times dailychildren under 2 years of age - consult a doctorDirections for Use as Relaxing Soak Solution:For external use only.  Pour Liberally into warm water no more than 4 times daily

Caution

If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician.  Individuals with diabetes should not use for hot or warm soaks unless advised by a physician.

Other Information

  • Does not conain, nor is intended as a substitute for grain or ethyl alcoholwill produce serious gastric distributances if taken internallyfumes can be acutely irritating to respiratory system.  Avoid inhaling this product

Inactive Ingredients

Water, isopropyl alcohol, Capsicum frutescens fruit extract, methyl salicylate, magnesium sulfate, red 40

Adverse Reaction

Distributed by: CVS Pharmacy, Inc.One CVS Drive, Woonsocket, RI 02895CVS Pharmacycvs.com 1-800-SHOP-CVS662.000/672AA

* Please review the disclaimer below.