NDC 69842-091 Cvs Medicated Heat

Capsicum Extract

NDC Product Code 69842-091

NDC 69842-091-03

Package Description: 3 PATCH in 1 POUCH > 1 PATCH in 1 PATCH

NDC Product Information

Cvs Medicated Heat with NDC 69842-091 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Cvs Medicated Heat is capsicum extract. The product's dosage form is patch and is administered via topical form.

Labeler Name: Cvs Pharmacy

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.

Cvs Medicated Heat 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.

  • CAPSICUM .025 mg/1

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.

  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
  • LANOLIN (UNII: 7EV65EAW6H)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • ROSIN (UNII: 88S87KL877)

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: 69842
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: 02-13-2019 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: 12-31-2020 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.

Cvs Medicated Heat Product Label Images

Cvs Medicated Heat 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

Otc - Active Ingredient

Active ingredient PurposeCapsicum extract 0.025% as Capsaicin.....................Topical analgesic

Otc - Purpose

  • Usestemporarily relieves minor pain of muscles and joints associated with:arthritissimple backachestrainssprainsbruises

Warnings

  • WarningsFor External use onlyAllergy alert:do not use if you are allergic to capsicum, chili peppers, or any ingredients in this productif prone to allergic reaction from aspirin or salicylates, consult a doctor before use

Otc - Do Not Use

  • Do not useon wounds or damaged skinwith a heating pad

Otc - When Using

  • When using this productdo not use otherwise than directedavoid contact with the eyes, mucous membranes or rashesdo not bandage tightlydiscontinue use at least 1 hour before a bath or showerdo not use immediately after a bath or shower

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsens, symptoms persist for more than 7 days or clear up and occur again within a few daysredness is present or irritation or rash developsa severe burning sensation occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Indications & Usage

  • Directionsadults and children 12 years of age and older:clean and dry affected arearemove patch from filmapply to affected area no more than 3 to 4 times dailydo not wear patch for more than 8 hourschildren under 12 years of age: consult a doctor

Storage And Handling

  • Other informationavoid storing product in direct sunlightprotect product from excessive moisture

Inactive Ingredient

Inactive ingredientslanolin, methyl salicylate, natural rubber, peppermint oil, petrolatum, rosin, zinc oxide

Dosage & Administration

Distributed by:CVS Pharmacy, Inc.One CVS DriveWoonsocket, RI 02895

* Please review the disclaimer below.

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