KOLORZ TOPICAL ANESTHETIC TRIPLE MINT
KOLORZ TOPICAL ANESTHETIC TRIPLE MINT is an FDA drug label for the active ingredient BENZOCAINE manufactured by DMG AMERICA, LLC administered by DENTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20211001.
Generic: BENZOCAINE
Manufacturer: DMG AMERICA, LLC
Product Type: HUMAN OTC DRUG
Route: DENTAL
Dosage Form:
NDC: 25047-751
Application: M022
Effective: 20211001
Active Ingredients: Active ingredients (in each gram) Benzocaine 200 mg
Indications & Usage
Use For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Dosage & Administration
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
Contraindications
Not available.
Warnings
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.
Adverse Reactions
Not available.