Label: COLD SORE TREATMENT- benzalkonium chloride tincture

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 9, 2009

If you are a consumer or patient please visit this version.

  • 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


    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.



    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.
  • SPL UNCLASSIFIED SECTION


  • 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 (70% v/v), water
  • QUESTIONS


  • PACKAGE INFORMATION - TRIFOLD INNER

    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).

    DIRECTIONS FOR USE

    1. CLEAN IT


    Prior 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. BREAK IT

    Remove 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.


    3. RUB IT

    The 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.

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  • PACKAGE INFORMATION - TRIFOLD OUTER

    CVS
    pharmacy                        

    NEW!

    NDC 50730-2000-1
    Compare to VIROXYN®

    SINGLE APPLICATION
    COLD SORE
    TREATMENT

    TREATS 2 COLD SORES

    • Cold sore / fever blister treatment and topical antiseptic
    • Unique patented applicator eliminates the need to touch the sore with your fingers
    • Instrucciones en espanol incluido

    2 Vials
    (0.6 ml)
    1 Vial per treatment


    CVS Quality Money Back Guarantee
    US Patent No's 6,211,243B1 and 6,322,243 and 6,410,599 and 6,414,032 and 6,423,750 and 6,759,434

    CVS/Pharmacy single application cold sore treatment uses a patented new approach 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 Simples virus (typically HSV-1) and are just different popular names for the HSV-caused lesions.

    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.

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

    ©2009 CVS/pharmacy www.cvs.com 1-800-shop-CVS


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  • INGREDIENTS AND APPEARANCE
    COLD SORE TREATMENT 
    benzalkonium chloride tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-2000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium chloride0.13 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    isopropyl alcohol (UNII: ND2M416302)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-2000-12 in 1 PACKAGE
    10.6 mL in 1 VIAL, PATENT DELIVERY SYSTEM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2007
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)