COLD SORE TREATMENT - benzalkonium chloride tincture 
Kmart Corporation

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.

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DRUG FACTS

ACTIVE INGREDIENT

Benzalkonium chloride, 0.13%

PURPOSE

Cold Sore / Fever Blister Treatment; Topical Antiseptic

USES

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: Children under 2 years of age: ask a doctor.


OTHER INFORMATION

INACTIVE INGREDIENTS

isopropyl alcohol, water


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:
It is possible to transfer the virus to other parts of the body (autoinoculation)

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.

Prior to use: Remove vial from package

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.


trifold inner

PACKAGE INFORMATION - TRIFOLD OUTER

NDC 49738-200-41

AMERICAN FARE®

NEW!
Compare to Viroxyn® active ingredient*

COLD SORE TREATMENT


Cold Sore / Fever Blister Treatment
and Topical Antiseptic


2 VIALS (0.6 ml each)


Made in U.S.A.
for Kmart Corporation
Hoffman Estates, IL 60179

US Patent No’s 6,211,243B1 and 6,322,243 and 6,410,599 and
6,414,032 and 6,420,431 and 6,423,750 and 6,759,434.

*Viroxyn® is a registered trademark of Quadex Pharmaceuticals, LLC


COLD SORE TREATMENT


American Fare 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 Simplex 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.
Satisfaction Guarantee:
If you are not satisfied with this or any Kmart Product, please call 1-800-842-7826. SHOP kmart.com


trifold outer

COLD SORE TREATMENT 
benzalkonium chloride tincture
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-200
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:49738-200-412 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 finalpart333A01/01/2009
Labeler - Kmart Corporation (008965873)

Revised: 4/2010
Document Id: fe437e83-2817-465f-b3cb-b2dd5fd16ec1
Set id: 8e66f470-a077-4f1c-a278-0f57ab196fd5
Version: 1
Effective Time: 20100415
 
Kmart Corporation