NDC 66506-180 Tibetree Pain Relieveing Plaster

Camphor

NDC Product Code 66506-180

NDC Code: 66506-180

Proprietary Name: Tibetree Pain Relieveing Plaster What 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 What 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.

NDC Code Structure

  • 66506 - Tibet Cheezheng Tibetan Medicine Co. Ltd.
    • 66506-180 - Tibetree Pain Relieveing Plaster

NDC 66506-180-03

Package Description: 5 PACKAGE in 1 PACKAGE > 1.2 g in 1 PACKAGE (66506-180-02)

NDC Product Information

Tibetree Pain Relieveing Plaster with NDC 66506-180 is a a human over the counter drug product labeled by Tibet Cheezheng Tibetan Medicine Co. Ltd.. The generic name of Tibetree Pain Relieveing Plaster is camphor. The product's dosage form is plaster and is administered via topical form.

Labeler Name: Tibet Cheezheng Tibetan Medicine Co. Ltd.

Dosage Form: Plaster - Substance intended for external application made of such materials and of such consistency as to adhere to the skin and attach to a dressing; plasters are intended to afford protection and support and/or to furnish an occlusion and macerating action and to bring medication into close contact with the skin.

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.

Tibetree Pain Relieveing Plaster 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.

  • CAMPHOR (NATURAL) 1 g/100g

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.

  • ZANTHOXYLUM BUNGEANUM FRUIT RIND (UNII: K447936H97)
  • CURCUMA LONGA WHOLE (UNII: W5488JUO8U)
  • CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)
  • PHLOMOIDES ROTATA WHOLE (UNII: 7CEU5N8573)
  • MYRICARIA PANICULATA STEM (UNII: 4C36LPC9I2)
  • OXYTROPIS CHILIOPHYLLA WHOLE (UNII: 9T7BW444B3)

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: Tibet Cheezheng Tibetan Medicine Co. Ltd.
Labeler Code: 66506
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: 04-30-2019 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.

Tibetree Pain Relieveing Plaster Product Label Images

Tibetree Pain Relieveing Plaster 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

Camphor 1%.................……….…….External analgesic

Otc - Ask Doctor

Do not use otherwise than as directed

Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental poisoning

If Pregnant

If pregnant, ask a health professional before use

Directions

  • Adults and children 12 years of age and older: remove plaster from the protective film, apply to the affected area as directed.Use 1 to 2 plasters every 24 hours for a consecutive five days as a treatment cycle.Apply the plaster to the affected area for 4 to 8 hours.Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.Children under 12 years of age: Do not use or consult a doctor.

Other Information

Store at room temperature, 20° to 25°C(68° to 77F)

Inactive Ingredients

Sichuan pepper pericarp, Lamiophlomis rotate root, Turmeric rhizome, Myricaria paniculata stem, Safflower flower, Oxytropis chiliophylla plant

Questions?

+1-510-780-9118

For External Use Only

For external use only

Purpose

External analgesic

Do Not Use

  • On woundsirritated or damaged skinsensitive skin

When Using This Product

  • Avoid contact with the eyesdo not use more than 2 plasters a daydo not use 1 hour before or after bathing

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysexcessive irritation of the skin developsredness is present

Warnings

For external use only

Uses

For the temporary relief of minor pain.

Tibetree Pdp.Jpg

Tibetree PDP.jpg

* Please review the disclaimer below.

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