NDC 49348-813 Cold Sore Treatment

NDC Product Code 49348-813

NDC 49348-813-94


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

NDC Product Information

Cold Sore Treatment with NDC 49348-813 is a product labeled by Mckesson. The generic name of Cold Sore Treatment is . The product's dosage form is and is administered via form.

Labeler Name: Mckesson

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the 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.

  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mckesson
Labeler Code: 49348
Start Marketing Date: 11-28-2006 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 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.

Exclude Flag: I 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cold Sore Treatment Product Label Images

Cold Sore Treatment Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Benzalkonium chloride, 0.13%


Cold Sore / Fever Blister Treatment; Topical Antiseptic


  • Treat cold sores / fever blistersHelp guard against infection


For external use only. Flammable, keep away from fire or flame.

Do Not Use

  • In the eyesover large areas of the bodyif you are allergic to any ingredient in the productmore than 3 times per daylonger than one week unless directed by a doctor.

Stop Use And Ask A Doctor If

  • Condition persists or worsenssymptoms persist for more than 7 days

Ask A Doctor If

  • Used to treat deep or puncture wounds, animal bites, or serious burnsyou 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.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.


  • 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 washclothRemove the cardboard top from applicator and place onto the glass/plastic vial end - opposite the brush end of the productSqueeze the cardboard to break the inner glass vial openSaturate the applicator end with solution by holding the brush end down and squeezing the container until you can see liquid on the brush applicatorFor 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 dayDiscard after use.Children under 2 years of age: ask a doctor.

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

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 49348-813-94Cold SoreTreatment Cold Sore / Fever Blister Treatment and Topical AntisepticTreats most cold sores in just one treatmentUnique patented applicator eliminates need to touch sore with your fingersSingle use applicator is easy to discardNo messy creams or ointmentsFAST PAIN RELIEF - 1 DAY, 1 DOSE2 VIALS - 0.6 mL eachAnother Quality Product Distributed by McKessonOne Post StreetSan Francisco, CA 94104Money Back GuaranteePlease visit us at www.sunmarkbrand.comUS Patent No. 6,211,243B1A 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 soapDo not touch your eyesDo 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.

* Please review the disclaimer below.