NDC 0363-9903 Pain Relieving Patches

Camphor Menthol Methyl Salicytate

NDC Product Code 0363-9903

NDC 0363-9903-40

Package Description: 40 POUCH in 1 BOX > 1 PATCH in 1 POUCH

NDC Product Information

Pain Relieving Patches with NDC 0363-9903 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Pain Relieving Patches is camphor menthol methyl salicytate. The product's dosage form is patch and is administered via topical form.

Labeler Name: Walgreen Company

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.

Pain Relieving Patches 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 5.7 1/1

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.

  • STYRENE (UNII: 44LJ2U959V)

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.
  • 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: Walgreen Company
Labeler Code: 0363
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: 11-15-2019 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.

Pain Relieving Patches Product Label Images

Pain Relieving Patches 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

Active IngredientPurpose Camphor 1.2% Topical Analgesic Menthol 5.7% Topical Analgesic Methyl Salicylate 6.3% Topical Analgesic

Keep Out Of Reach Of Children

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

Indications & Usage

For temporary relief of minor aches and pains of muscles and joins: arthritis, simple backache, muscle strains, muscle sprains and bruises.


For External Use OnlyAllergy Alert:If prone to allergic reactions from aspirine or salicytates, consult a doctor before use.

Dosage & Administration

Adults and children over 12 years: Clean and dry affected area. Remove patch from film, apply to affected area not more than 3-4 times a day.Do not use for more than 8 hours. Discard patch after use.Children under 12 years of age, consult a physician.Reseal pouch after opening.


Topical Analgesic

When Using This Product:

  • Use only as directedAvoid contact with eyes, mucous membranes or rashes.DIspose of used patches away from children and pets. Used patches still contain the drug product which can produce serious adverse effects if children or pets chews or ingests the patch.

Do Not Use

  • On wounds or damaged skinWith a heating padIf you are allergic to any ingredients in this product. Otherwise then as directed.

Top Use And Consult A Doctor

  • If rash, itching or excessive skin irritation developsIf condition worsensIf symptoms last more than 7 days or clear up and occur again in a few days.

Storage And Care

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Pain Relieving Path

DIST. BYWalgreens Co.200 Wilmot Rd. Deerfield, IL 60015www.walgreens.com
TOLL-FREE CUSTOMER CARE HELP LINE Mon–Fri, 8:30 am–4:30 pm CST 866-326-1313

* Please review the disclaimer below.