NDC 81484-201 Pain Relief Patchs

Camphor, Menthol, Methyl Salicylate

NDC Product Code 81484-201

NDC 81484-201-02

Package Description: 2 BAG in 1 BOX > 5 PATCH in 1 BAG (81484-201-01)

NDC 81484-201-03

Package Description: 10 PATCH in 1 BOX

NDC Product Information

Pain Relief Patchs with NDC 81484-201 is a a human over the counter drug product labeled by Anhui Miao De Tang Pharmaceutical Co., Ltd.. The generic name of Pain Relief Patchs is camphor, menthol, methyl salicylate. The product's dosage form is patch and is administered via topical form.

Labeler Name: Anhui Miao De Tang Pharmaceutical Co., Ltd.

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 Relief Patchs 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.

  • METHYL SALICYLATE 3.1 g/1
  • MENTHOL 5.2 g/1
  • CAMPHOR (SYNTHETIC) 3.8 g/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.

  • NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
  • LANOLIN (UNII: 7EV65EAW6H)
  • BORNEOL (UNII: M89NIB437X)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • 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: Anhui Miao De Tang Pharmaceutical Co., Ltd.
Labeler Code: 81484
Marketing Category: UNAPPROVED DRUG OTHER - 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: 04-07-2021 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.

Pain Relief Patchs Product Label Images

Pain Relief Patchs 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

Other

Pain Relief Patchs

Active Ingredient(S)

Camphor 3.8g/patch

Menthol 5.2g/patch

Methyl Salicylate 3.1g/patch

Purpose

Topical Analgesic, Pain Relief Patch

Use

Use to the adjuvant treatment of pain caused by cervical spondylosis, frozen shoulder, lumbar disc herniation, rheumatoid arthritis, and bone or joint or soft tissue injury.

Warnings

For external use only.

Do Not Use

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

Otc - When Using

  • Use only as directedAvoid contact with eyes, mucous membranes or rashesDo not bandage tightlyDo not use at the same time as other topical analgesicsDispose of used patch in manner that keeps product away from children 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.

Otc - Stop Use

  • 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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For temporary relief of minor aches and pains.

Other Information

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

Inactive Ingredients

Colophony

Lanolin

Borneol

Vaseline

Natural Rubber

* Please review the disclaimer below.