NDC 81654-001 Moxa Roll

Moxa Roll

NDC Product Code 81654-001

NDC 81654-001-01

Package Description: 600 BOTTLE in 1 BOX > 20 mL in 1 BOTTLE

NDC Product Information

Moxa Roll with NDC 81654-001 is a a human over the counter drug product labeled by Shandong Nuannuanai Chinese Medicinal Materials Import & Export Co., Ltd.. The generic name of Moxa Roll is moxa roll. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Shandong Nuannuanai Chinese Medicinal Materials Import & Export Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Moxa Roll 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.

  • CARYOPHYLLENE 26 g/100mL
  • 4-TERPINEOL, (+/-)- 32 g/100mL

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.

  • .ALPHA.-PHELLANDRENE (UNII: 49JV13XE39)
  • .ALPHA.-CUBEBENE, (-)- (UNII: 438H9S5RG9)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • BORNEOL, (+)- (UNII: 8D24LWT4FK)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)

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: Shandong Nuannuanai Chinese Medicinal Materials Import & Export Co., Ltd.
Labeler Code: 81654
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 03-04-2021 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.

Moxa Roll Product Label Images

Moxa Roll 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

Ndications And Uses

Sub-healthy people with joint pain such as neck, shoulder, waist,knee, etc., women with frequent abdominal pain, etc.

How To Use

Lgnite the moxa stick, aim at the acupoints for fumigation, and warmthe skin to make the skin flush.

The appropriate time is 30 minutes.

Otc - Active Ingredient

Terpinenol-4β-Caryophyllene

Otc - Purpose

Soothes muscles and bones, drives away the cold

Otc - When Using

Available during normal hours

Otc - Stop Use

Stop smoking for about 30 minutes

Otc - Keep Out Of Reach Of Children

PLEASE KEEP THIS PRODUCT oUT OF REACH OF CHILDREN

Inactive Ingredient

LinaloolCamphorae

Cineol,Eucalypto
BorneolPhellandreneCadinene

Warnings

1.The skin is allergic to wormwood;

2.Drinking is prohibited;

3.Prohibited by pregnant women.

Storage And Handling

Store in a cool and dry place

* Please review the disclaimer below.