FDA Label for Kolorz Topical Anesthetic Triple Mint

View Indications, Usage & Precautions

Kolorz Topical Anesthetic Triple Mint Product Label

The following document was submitted to the FDA by the labeler of this product Dmg America, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

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

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.

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

1 FL OZ (29.6 grams)

RINCIPAL DISPLAY PANEL - 29.6 grams Bottle Label - Piña Colada - kolorz 05

* Please review the disclaimer below.

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