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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;
Irxsinorel
FDA Label NDC 72586-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Activpower Inc. for the product Irxsinorel (NDC 72586-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, when using this product, stop use and ask doctor if, if pregnant or breast-feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredient | Purpose |
|---|---|
| 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
Principal Display Panel (50 ml Bottle Label)
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