NDC 72586-005 Irxsinorel

Product Information

Irxsinorel is product labeled by Activpower Inc.. The product's dosage form is and is administered via form.

Product Code72586-005
Proprietary Name 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.
Irxsinorel
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Activpower Inc.
Labeler Code72586
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-01-2020
Listing Expiration Date 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.
12-31-2021
Exclude Flag 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".
I
NDC Code Structure

What are the uses for Irxsinorel?


Product Packages

NDC 72586-005-01

Package Description: 50 mL in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

What are Irxsinorel Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (Active Moiety)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (Active Moiety)

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.
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • CASTOR OIL (UNII: D5340Y2I9G)

* Please review the disclaimer below.

Irxsinorel Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts

Manufactured for/by ActivPower Inc.,Delaware, U.S.A
under license from ActivPower Inc. 13505 Dulles
Technology Drive, Suite 1A, Herndon, VA 20171, USA;


Otc - Purpose



Active IngredientPurpose
Camphor 10%Topical analgesic
Menthol 10%Topical analgesic

Uses



For application on to intact unbroken skin to help achieve the temporary relief of sinus pain.


Warnings



For external use only.


When Using This Product



Avoid contact with eyes and mucous membranes, wounds, damaged or irritated skin. Do not bandage or cover with wrap or apply any heat or heating pad to area after use. Wash hands with soap and water after using this product.


Stop Use And Ask Doctor If



Condition worsens. Severe skin irritation occurs. Pain persists for more than 4 days. Pain clears up and then recurs after a few days.


If Pregnant Or Breast-Feeding



This product has not been tested in pregnant or breast-feeding women. Consult the advice of your doctor before using this product in these situations.


Keep Out Of Reach Of Children



Not recommended for use in children 12 years old or younger. If swallowed, get medical help or contact Poison Control immediately. If exposure to eyes, then wash copiously with cold water and consult a doctor. Components are not certified to be free of nut allergens. Do not use if allergic to nuts or peanuts or if allergic to any of the components without testing. Use on a small area for the first time. If rash or itching develops then discontinue use. If symptoms persist then consult a medical professional. If the intended area of application or joint is hot, red, bruised or swollen then do not apply this liniment and immediately seek professional medical help.


Inactive Ingredients



Eucalyptus Oil; Castor Oil;


Directions For Use



For Topical use. Apply 2ml-3ml into forehead and over cheek sinuses and rub in gently until it vanishes. May apply up to twice daily. Do not exceed recommended frequency of application. Do not apply heat after application. This product will produce a soothing relief and sensation of cooling in the area of application.


Questions/Comments



703-404-5905


Principal Display Panel - 50 Ml Bottle Label



IRx SinoRel

Topical Sinus Pain Analgesic Relief
Doctor created. Clinic proven
Time tested Herbal Relief

Net Quantity: 50ml


* Please review the disclaimer below.