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FDA LABEL GENERIC: Benzocaine MFR: DMG AMERICA, LLC

Kolorz Anesthetic 0.2 Mg/mg Oral Gel

Drug Facts

Active ingredients (in each gram)

Benzocaine 200 mg

Purpose

Oral Anesthetic

Use

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Warnings

Methemoglobinemia warning

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

pale, gray, or blue colored skin (cyanosis) headache rapid heartrate shortness of breath dizziness or lightheadedness fatigue or lack of energy

Allergy alert

Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persist or worsen, see your dentist or doctor promptly.

Do not use

for teething in children under 2 years of age

When using this product

Avoid contact with eyes. If contact occurs, flush with water.

If pregnant or breast feeding, consult a doctor before use.

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

adults and children 2 years of age and older: apply only amount needed to the oral mucosa to prevent or relieve pain children under 2 years of age: do not use

Other information

Store at 59 - 86°F (15 - 30°C). Protect from freezing.

Inactive ingredients

flavoring, PEG 3350, PEG 400, sucralose. May contain D&C Red #33, FD&C Red #40, D&C Green #5, FD&C Yellow #5, FD&C Blue #1 as a color additive.

Questions or comments?

800-6626383 • www.dmg-america.com

Distributed by DMG America LLC
242 South Dean St., Englewood, NJ 07631

PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Triple Mint

Best Taste...
Guaranteed!

kolorz®

Topical Anesthetic Gel
(Benzocaine 20%)
Triple Mint

1 FL OZ (29.6 grams)

PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Cherry Burst

Best Taste...
Guaranteed!

kolorz®

Topical Anesthetic Gel
(Benzocaine 20%)
Cherry Burst

1 FL OZ (29.6 grams)

PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Cotton Candy

Best Taste...
Guaranteed!

kolorz®

Topical Anesthetic Gel
(Benzocaine 20%)
Cotton Candy

1 FL OZ (29.6 grams)

PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Blue Raspberry

Best Taste...
Guaranteed!

kolorz®

Topical Anesthetic Gel
(Benzocaine 20%)
Blue Raspberry

1 FL OZ (29.6 grams)

PRINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Piña Colada

Best Taste...
Guaranteed!

kolorz®

Topical Anesthetic Gel
(Benzocaine 20%)
Piña Colada

1 FL OZ (29.6 grams)