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Drug Facts
Quadex Labs
6975 Union Park Center #300
Salt Lake City, Utah 84047
www.viroxyn.com
1-877-825-7153
Viroxyn Professional Use
FDA Label NDC 66774-1003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quadex Pharmaceuticals Llc for the product Viroxyn Professional Use (NDC 66774-1003). 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, warning, do not use, otc - stop use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients: | Purposes: |
|---|---|
| Benzalkonium Chloride 0.3% | Cold Sore/Fever Blister Treatment |
| Benzocaine 7.5% | Pain Relief During Application |
Uses
- To treat cold sores/fever blisters.
Warning
- For external use only.
- Flammable; keep away from fire or flame
Do Not Use
- In the eyes
- Longer than one week, unless directed by a doctor
- If you are allergic to any ingredient in this product
- Over large areas of the body
- More than 3 times a day
Otc - Stop Use
Stop use and ask a doctor if:
- Condition persists or worsens
- Symptoms persist for more than 7-10 days
Otc - Ask Doctor
Ask a doctor if:
- You are pregnant or nursing a baby
Otc - When Using
When using this product you may feel a brief stinging sensation when you apply it. The sting should go away in a short time.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions – Adults And Children Over 2 Years Of Age
- Using only warm water and a washcloth, clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick.
- Remove the cardboard cap from the applicator end and place the cardboard cap on to the glass/plastic vial end, opposite the brush end of the product.
- Squeeze the cardboard cap to break open the inner glass vial.
- Saturate the applicator end with solution by holding the brush end down and squeezing the container until you can see liquid on the brush applicator.
- Touch the cold sore with the wet applicator and allow the numbing agent a few moments to numb your lip. Then begin actual treatment.
- For best results, message the solution into the cold sore by rubbing. Rub firmly, but take care not to damage the tissue. The purpose of the rubbing is to deliver the drug to the infection site. Hold the vial so the solution flows to the sore.
- To treat most cold sores, usually one treatment is enough. If you symptoms go away and then return later, apply another dose for the second cold sore.
- Do not use more than 3 times a day.
- Children under 2 years of age – ask a doctor or dentist.
- Discard after use.
Other Information
Store at room temperature. The ingredients in toothpaste, soft drinks, and some fruit juices can deactivate the active ingredient in Viroxyn Professional Use®. For best results, avoid brushing your teeth with toothpaste or drinking sodas or fruit juices for at least one hour after applying the drug. Some people may notice a thin white powder on the lips after treatment. This is benzocaine that did not get absorbed into the lip and is normal.
Inactive Ingredients
Isopropyl alcohol (70% v/v), water
Otc - Questions
Questions or to report an adverse event: 1-877-825-7153
Principal Display Panel - 2 Vial Carton
NDC 66774-1003-2
Professional Use
Cold Sore Treatment
Viroxyn®
PROFESSIONAL USE
WITH 7.5%
BENZOCAINE
Cold Sore Treatment
Relieves Pain
Starts Healing
Just One Dose
Available ONLY through medical professionals.
Contents: 2 Vials (0.6 ml)
Principal Display Panel (2 Vial Carton)
* Please review the disclaimer below.
