NDC 73412-001 Hua Tuo Medicated Plaster Extra Strength

Menthol Camphor

NDC Product Code 73412-001

NDC 73412-001-05

Package Description: 5 PATCH in 1 BOX

NDC Product Information

Hua Tuo Medicated Plaster Extra Strength with NDC 73412-001 is a a human over the counter drug product labeled by Wah Ning Pharmaceutical (international) Limited. The generic name of Hua Tuo Medicated Plaster Extra Strength is menthol camphor. The product's dosage form is patch and is administered via topical form.

Labeler Name: Wah Ning Pharmaceutical (international) Limited

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.

Hua Tuo Medicated Plaster Extra Strength 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 3 g/1
  • CAMPHOR (SYNTHETIC) 10 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.

  • ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
  • ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)
  • BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)
  • CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)
  • CINNAMON OIL (UNII: E5GY4I6YCZ)
  • CLOVE OIL (UNII: 578389D6D0)
  • COMMIPHORA AFRICANA RESIN (UNII: W30OSW7A0S)
  • DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)
  • ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)
  • GINGER (UNII: C5529G5JPQ)
  • GLECHOMA LONGITUBA WHOLE (UNII: 79GOE5902E)
  • PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)
  • SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)
  • NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)

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: Wah Ning Pharmaceutical (international) Limited
Labeler Code: 73412
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: 10-01-2019 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.

Hua Tuo Medicated Plaster Extra Strength Product Label Images

Hua Tuo Medicated Plaster Extra Strength 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 3%

Camphor10%

Purpose

External AnalgesicExternal Analgesic

Uses

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

Warnings

For external use only ■
Do not use ■ do not apply to wounds or damaged skin
■ discontinue use if excessive irritation of the skin develops ■ condition affect children uner 12 years of age

When Using This Product

■ Avoid contact with the eyes or mucus membranes ■ do not bandage tightly ■ Do not use otherwise than as directed

Stop Use And Ask A Doctor If

■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.■ redness is present

Keep Out Of Reach Of Children

In case of accidental ingestion, contact a doctor or Poison Control Center immediately

Directions

■ Adults and children 12 years of age and older remove the clear film backing and apply to affected area not more than 3 to 4 times daily■ Children under 12 years of age, consult a doctor before using.■ Use caution when applying to hairy skin areas, highly adhesive plaster can hurt when removing.

Other Information

■ Store at 68-77ºF (20-25C)

Inactive Ingredients

Angelica dahurica root, angelica pubescens root, boswellia sacra whole, carthamus tinctorius flower, cinnamon oil, clove oil, commiphora africana resin, drynaria fortunei root, eleutherococcus nodiflorus root bark, ginger, glechoma longituba whole, panax notoginseng root, saposhnikovia divaricata root, schizonepeta tenuifolia flowering top

* Please review the disclaimer below.