![VIROXYN PROFESSIONAL USE (BENZALKONIUM CHLORIDE AND BENZOCAINE) LIQUID [QUADEX PHARMACEUTICALS LLC]](https://medic.hrt.org//dailymed/images/a7576e67-f1df-4653-a0bf-0495ec4883b1/viroxyn-01.jpg)
| NDC | 66774-1003-2, 66774-1003-3, 66774-1003-4, 66774-1003-5 |
| Set ID | a7576e67-f1df-4653-a0bf-0495ec4883b1 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Quadex Pharmaceuticals LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART348 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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
Stop use and ask a doctor if:
- Condition persists or worsens
- Symptoms persist for more than 7-10 days
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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.
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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
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 2 Vial Carton
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INGREDIENTS AND APPEARANCE
VIROXYN PROFESSIONAL USE
benzalkonium chloride and benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66774-1003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium chloride 1.14 mg in 1 mL Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 65.775 mg in 1 mL Inactive Ingredients Ingredient Name Strength Isopropyl Alcohol (UNII: ND2M416302) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66774-1003-2 2 in 1 BLISTER PACK 1 0.6 mL in 1 AMPULE 2 NDC:66774-1003-3 3 in 1 BLISTER PACK 2 0.6 mL in 1 AMPULE 3 NDC:66774-1003-4 6 in 1 BOX 3 0.6 mL in 1 AMPULE 4 NDC:66774-1003-5 12 in 1 BLISTER PACK 4 0.6 mL in 1 AMPULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 10/22/2012 Labeler - Quadex Pharmaceuticals LLC (090438909) Establishment Name Address ID/FEI Business Operations Quadex Pharmaceuticals LLC 090438909 MANUFACTURE(66774-1003)
