COLD SORE TREATMENT - benzalkonium chloride tincture 
H and P Industries, Inc. dba Triad Group

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 (70% v/v), water


PACKAGE INFORMATION - TRIFOLD INNER

1. CLEAN

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

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

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.

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.

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PACKAGE INFORMATION - TRIFOLD OUTER

NDC 50730-1001-1


CARE ONE  

1 DAY, 1 DOSE AND HEALING BEGINS
COLD SORE
TREATMENT

Benzalkonium Chloride, 0.13%

COLD SORE/FEVER BLISTER TREATMENT

Treats most cold sores in just one treatment
Patented applicator eliminates need to touch sore with fingers
No Messy creams or ointments left on the face
Instrucciones en espanol incluido


2 Vials
0.6 ml each

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

*Viroxyn is a registered trademark of Quadex Pharmaceuticals LLC.

Distributed by: American Sales Company
4201 Walden Avenue
Lancaster, NY 14086
S and S Brands, Inc.
www.Care1.info

Quality Guaranteed or your money back.
Made in U.S.A.


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.

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:

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.

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COLD SORE TREATMENT 
benzalkonium chloride tincture
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-1001
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:50730-1001-12 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)

Revised: 12/2009
Document Id: 12b9b3c5-5a05-4595-87bc-cc53bcbf1fd7
Set id: 8daf4144-65b3-42cf-a2f8-4ebc47baf2d1
Version: 1
Effective Time: 20091209
 
H and P Industries, Inc. dba Triad Group