BLISTER BLASTER- benzalkonium chloride liquid

Blister Blaster by

Drug Labeling and Warnings

Blister Blaster by is a Otc medication manufactured, distributed, or labeled by Quadex Pharmaceuticals, LLC, James Alexander Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Benzalkonium Chloride 0.13%

Purposes

Cold Sore/Fever Blister Treatment Topical Antiseptic

Uses

• To treat cold sores/fever blisters.
• To help guard against infection.

Warning

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

Do not use:

• in the eyes.
• over large areas of the body.
• longer than one week unless directed by a doctor.
• more than 3 times per day.
• if you are allergic to any ingredient in this product.

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 you apply 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

• Using only warm water and a washcloth, clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick.
• Remove the cardboard cap from the applicator end and place the cardboard cap onto the glass/plastic vial end, opposite the brush end of the product.
• Squeeze the cardboard cap to break open the inner glass vial.
• 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 for the second cold sore.
• Do not use more than 3 times per day.
• Children under 2 years of age — ask a doctor.
• Discard after use.

Other information

Store at room temperature. The ingredients in toothpaste, soft drinks, and some fruit juices can deactivate the active ingredient in Blister Blaster. For best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for at least one hour after applying the drug.

Inactive ingredients

Isopropyl alcohol (70% v/v), water.

QUESTIONS

Questions or to report an adverse event: 1-877-825-7153

PRINCIPAL DISPLAY PANEL - 0.6 ml Vial Blister Pack

NDC: 66774-1001-2

blisterblaster®

One Day,
One Dose,
Healing Begins.

Finally, a cold sore treatment that actually
works—so you can clear away that THING
on your lip right now!

Relieves Pain and Burning

Not available through retail stores; avoid imitations.

Contents: 2 Vials (0.6 ml)

INGREDIENTS AND APPEARANCE

BLISTER BLASTER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66774-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium chloride	0.12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Isopropyl Alcohol (UNII: ND2M416302)	70 mL  in 100 mL
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66774-1001-2	2 in 1 BLISTER PACK
1		0.6 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	04/01/2010

Labeler - Quadex Pharmaceuticals, LLC (090438909)

Establishment
Name	Address	ID/FEI	Business Operations
James Alexander Corporation		040756421	MANUFACTURE