NDC 51367-033 Shexiang Zhuanggu Gao

Camphor, Menthol, Methyl Salicylate

NDC Product Code 51367-033

NDC Code: 51367-033

Proprietary Name: Shexiang Zhuanggu Gao 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, Menthol, Methyl Salicylate 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

  • 51367 - International Nature Nutraceuticals
    • 51367-033 - Shexiang Zhuanggu Gao

NDC 51367-033-10

Package Description: 10 PLASTER in 1 BOX

NDC Product Information

Shexiang Zhuanggu Gao with NDC 51367-033 is a a human over the counter drug product labeled by International Nature Nutraceuticals. The generic name of Shexiang Zhuanggu Gao is camphor, menthol, methyl salicylate. The product's dosage form is plaster and is administered via topical form.

Labeler Name: International Nature Nutraceuticals

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.

Shexiang Zhuanggu Gao 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) 30.53 mg/1
  • MENTHOL 40.71 mg/1
  • METHYL SALICYLATE 25.95 mg/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.

  • STAR ANISE (UNII: XKC1657P78)
  • ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
  • ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)
  • ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
  • GINGER (UNII: C5529G5JPQ)
  • CYNANCHUM PANICULATUM WHOLE (UNII: T14ONG8D7H)
  • KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI)
  • GERANIUM WILFORDII WHOLE (UNII: QXI974Y72W)
  • CYATHULA OFFICINALIS ROOT (UNII: BRM37UP34O)
  • MUSCONE (UNII: UPS3C6CV36)
  • CHONDROITIN SULFATE (PORCINE) (UNII: V5E8ELO4W9)
  • BORNEOL (UNII: M89NIB437X)
  • NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
  • ROSIN (UNII: 88S87KL877)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • LANOLIN (UNII: 7EV65EAW6H)
  • PARAFFIN (UNII: I9O0E3H2ZE)

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: International Nature Nutraceuticals
Labeler Code: 51367
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: 04-15-2019 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.

Shexiang Zhuanggu Gao Product Label Images

Shexiang Zhuanggu Gao 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 1.91%   External AnalgesicMenthol 2.54%:   External AnalgesicMethyl Salicylate 1.62%:   External Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:Simple backacheArthritisStrainsBruisesSprains

Do Not Use

On woundsOn irritated or damaged skinIf the appearance of this product has changedIn excess of 12 hoursIf known sensitivity this productOtherwise than as Directed

Ask A Doctor Or Pharmacist Before Use If You Are:

Pregnant, or taking other medications

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 developsWhen Using for pain of arthritisPain persists for more than 10 daysredness is presentIn conditions affecting children under 12 years of age

Keep Out Of Reach Of Children

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

Warnings:

For External Use Only

Directions

Adults and Children 12 years of age and older: apply one or two plasters to affected area once a day, remove after 12 hoursChildren 2 to 12 years of age and adults with compromised health: use only the guidance of a doctorChildren under 2 years of age: do not use

Allergy Alert:

This product contains natural rubber latex which may cause allergic reactionsOther Information:Keep container tightly closedStore below 20C in a dry area.

Inactive Ingredients

STAR ANISEANGELICA DAHURICA ROOT ATRACTYLODES LANCEA ROOT ANGELICA SINENSIS ROOT GINGER CYNANCHUM PANICULATUM WHOLE KAEMPFERIA GALANGA ROOT GERANIUM WILFORDII WHOLE CYATHULA OFFICINALIS ROOT MUSCONE CHONDROITIN SULFATE (PORCINE) BORNEOL NATURAL LATEX RUBBER ROSIN ZINC OXIDE PETROLATUMLANOLIN PARAFFIN

* Please review the disclaimer below.

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