NDC 49348-813 Cold Sore Treatment

Product Information

Cold Sore Treatment is product labeled by Mckesson. The product's dosage form is and is administered via form.

Product Code49348-813
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Cold Sore Treatment
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Mckesson
Labeler Code49348
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
11-28-2006
Listing Expiration Date 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.
12-31-2017
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

What are the uses for Cold Sore Treatment?


Product Packages

NDC 49348-813-94

Package Description: 2 VIAL, PATENT DELIVERY SYSTEM in 1 PACKAGE > .6 mL in 1 VIAL, PATENT DELIVERY SYSTEM

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

Product Details

What are Cold Sore Treatment Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BENZALKONIUM (UNII: 7N6JUD5X6Y) (Active Moiety)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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.
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • WATER (UNII: 059QF0KO0R)

* Please review the disclaimer below.

Cold Sore Treatment Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



Benzalkonium chloride, 0.13%

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.




* Please review the disclaimer below.