ORAJEL FOR COLD SORES SINGLE DOSE- benzalkonium chloride, benzocaine liquid

Orajel for Cold Sores by

Drug Labeling and Warnings

Orajel for Cold Sores by is a Otc medication manufactured, distributed, or labeled by Team Technologies, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

Benzalkonium chloride, 0.13%
Benzocaine, 5%

PURPOSE

PURPOSE

Topical Antiseptic
Pain Reliever

INDICATIONS & USAGE

USES

• to treat cold sores / fever blisters

WARNINGS

WARNINGS

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

Allergy alert:  do not use this product if you  have a  history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Do not use

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

Stop use and ask a dentist or physician if

• condition persists or worsens
• symptoms persist for more than 7 days

Ask a physician 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

KEEP OUT OF REACH OF CHILDREN

In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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 only warm water or alcohol
• Slide off to remove the protective blue paper cover and slide it on the other end-opposite the white applicator tip
• Squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap
• Hold with the white applicator tip down to allow the medication to saturate the tip
• To minimize pain during application gently touch the site of the cold sore with the saturated applicator tip. Once the area is numb, rub the site of the cold sore and the surrounding area.  Rub firmly to allow the treatment to deeply penetrate the skin.
• 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
• Discard after use.

Children under 2 years of age: ask a dentist or physician.

OTHER INFORMATION

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

INACTIVE INGREDIENT

INACTIVE INGREDIENTS
isopropyl alcohol (70% v/v), water

QUESTIONS

Questions or coments? call us at 1-800-952-5080 M-F ET or visit our website at www.orajel.com

PRINCIPAL DISPLAY PANEL

Orajel
Instant Pain Relief

FOR COLD SORES

Serious Relief for Serious Cold Sores

SINGLE DOSE

Patented Cold Sore Treatment

Topical Antiseptic/Topical Anesthetic

Touch-Free Applicator

INGREDIENTS AND APPEARANCE

ORAJEL FOR COLD SORES  SINGLE DOSE
benzalkonium chloride, benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67659-150(NDC:10237-756)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg  in 1 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67659-150-25	0.08 g in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product	09/09/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/01/2012

Labeler - Team Technologies, Inc (192339703)

Registrant - Team Technologies, Inc (192339703)

Establishment
Name	Address	ID/FEI	Business Operations
Team Technologies, Inc		079337800	repack(67659-150) , relabel(67659-150)