NDC 70000-0368 Pain Relief Patches

Camphor, Menthol, Methyl Salicylate

NDC Product Code 70000-0368

NDC Code: 70000-0368

Proprietary Name: Pain Relief Patches Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Camphor, Menthol, Methyl Salicylate Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 70000 - Cardinal Health
    • 70000-0368 - Pain Relief Patches

NDC 70000-0368-1

Package Description: 6 PATCH in 1 BOX > 9 g in 1 PATCH

NDC Product Information

Pain Relief Patches with NDC 70000-0368 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Pain Relief Patches is camphor, menthol, methyl salicylate. The product's dosage form is patch and is administered via topical form.

Labeler Name: Cardinal Health

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 Additional informationCallout TooltipWhat 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 Relief Patches Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CAMPHOR (SYNTHETIC) 3.1 g/100g
  • MENTHOL 6 g/100g
  • METHYL SALICYLATE 10 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
  • PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
  • LIQUID PETROLEUM (UNII: 6ZAE7X688J)
  • STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cardinal Health
Labeler Code: 70000
FDA Application Number: part348 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-01-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Relief Patches Product Label Images

Pain Relief 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 Ingredients

Active Ingredients PurposeCamphor 3.1% ......................Topical AnalgesicMenthol 6.0% .......................Topical AnalgesicMethyl Salicylate 10.0% ........Topical Analgesic

For External Use Only

Allergy alert: If prone to allergic reaction from asprin or salicylates, consult a doctor before use

Do Not Use:

  • On wounds or damaged skinWith a heating padIf you are allergic to any ingredients of this product

When Using This Product

  • Use only as directedAvoid contact with eyes, mucous membranes or rashesDo not bandage tighlyDo not use at the same time as other topical analgesicsDispose of used patch in manner that keeps product away from childrens and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Questions

Customer Care Help Line1-866-326-1313

Stop 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 with a few days

Keep Out Of Reach Of Children

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

Uses

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.

Directions

Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from film, apply to affected area not more than 3 to 4 times daily. Remove patch from the skin after at most, 8-hour application.Children under 12 years of age: consult physician.

Inactive Ingredients

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Indication And Usage

For temporary relief of minor aches and pains.

Pain Relief Patch Label

Other Information: Store in clean, dy place outside of direct sunlight. Protect from excessive moisture.

* Please review the disclaimer below.

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