Active Ingredient
Benzalkonium chloride, 0.13%
Cold Sore Treatment
FDA Label NDC 49348-813
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Cold Sore Treatment (NDC 49348-813). 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 active ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if, otc - ask doctor/pharmacist, ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cold Sore / Fever Blister Treatment; Topical Antiseptic
Uses
- Treat cold sores / fever blisters
- Help guard against infection
Warnings
For external use only. Flammable, keep away from fire or flame.
Do Not Use
- in the eyes
- over large areas of the body
- if you are allergic to any ingredient in the product
- more than 3 times per day
- longer than one week unless directed by a doctor.
Stop Use And Ask A Doctor If
- condition persists or worsens
- symptoms persist for more than 7 days
Otc - Ask Doctor/Pharmacist
Ask A Doctor If
- used to treat deep or puncture wounds, animal bites, or serious burns
- you are pregnant or nursing a baby
When Using This Product
You may feel a brief stinging sensation when applying it. The sting should go away in a short time.
Otc - Pregnancy Or Breast Feeding
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:
- Clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics including lipstick using warm water and a washcloth
- Remove the cardboard top from applicator and place onto the glass/plastic vial end - opposite the brush end of the product
- Squeeze the cardboard to break the inner glass vial open
- 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
- For best results, massage 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 your symptoms go away and then return later, apply another dose.
- Do not use more than 3 times per day
- Discard after use. Children under 2 years of age: ask a doctor.
Other
Other Information
- Store at room temperature: 15° - 30° C (59° - 86° F)
- The ingredients in toothpaste, softdrinks, and some fruit juices can de-activate the active ingredient. For best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for one hour after applying.
Inactive Ingredients
Isopropyl alcohol, water
Otc - Questions
Package Information - Trifold Inner
1. CLEANPrior to treatment, clean the area to be treated preferably with a washcloth and warm water. A dry wipe may be sufficient. Do not use soap or other cleansers.2. BREAKRemove paper cap from vial, exposing applicator tip.Replace cap on other end of vial, leaving applicator tip exposed.Firmly pinch center of vial, close to edge of paper cap, until inner ampoule breaks.Hold with the white applicator tip down, allowing medication to saturate the applicator.If necessary: pinch vial gently until a drop of medication appears.Prior to use: Remove vial from package3. RUBThe key is to rub on the sore and the surrounding area. Gently dabbing is not effective.Do not rub so hard that you cause damage to the skin.Keep the applicator saturated at all times. If necessary, pause and hold the vial to allow more medication to flow into the applicator tip.Use all the medication in the vial.Dispose of when finished, recap the vial and dispose of immediately. Do not disassemble; keep out of reach of children.Occasionally an additional treatment may be required. In some people, a lesion may appear to start healing and recur a day or more later. This will require an additional treatment.
Package Information - Trifold Outer
Sunmark®
NDC 49348-813-94
Cold Sore
Treatment
Cold Sore / Fever Blister Treatment
and Topical Antiseptic
Treats most cold sores in just one treatment
Unique patented applicator eliminates need to touch sore with your fingers
Single use applicator is easy to discard
No messy creams or ointments
FAST PAIN RELIEF - 1 DAY, 1 DOSE
2 VIALS - 0.6 mL each
Another Quality Product
Distributed by McKesson
One Post Street
San Francisco, CA 94104
Money Back Guarantee
Please visit us at
www.sunmarkbrand.com
US Patent No. 6,211,243B1
A patented new approach (US 6,211,243B1) to treating cold sores - rubbing the cold sore with the applicator tip delivers the germicidal medicine directly to the site of the infection.
Cold Sores and Fever Blisters are both caused by the Herpes Simplex virus (typically HSV-1) and are just different popular names for the HSV-caused lesions.
HERPES IS HIGHLY CONTAGIOUS.
A well-intentioned kiss can transfer the virus to another individual. Children are highly at risk.
After touching a cold sore:
- Wash your hands immediately with warm water and soap
- Do not touch your eyes
- Do not touch your genitals or other parts of the body. It is possible to transfer the virus to other parts of the body (autoinoculation)
Occasionally an additional treatment may be required. In some people, a lesion may appear to start healing and recur a day or more later. This will require an additional treatment.
Trifold Outer (44 1011c Out A1106)
* Please review the disclaimer below.
