Drugplain

KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY 200 mg/g

BENZOCAINE · GEL · DMG AMERICA, LLC

No Recall History
Plain English

KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY is a gel containing benzocaine at 200 mg/g, taken dental. Manufactured by DMG AMERICA, LLC.

Key Facts

Brand Name
KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY
Generic Name
BENZOCAINE
NDC Code (Product)
25047-754
Manufacturer
DMG AMERICA, LLC
Strength
200 mg/g
Dosage Form
GEL
Route
DENTAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
09/06/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

methaemoglobinaemia124 reports
drug ineffective89 reports
drug hypersensitivity61 reports
off label use59 reports
asthenia48 reports
nausea47 reports
dyspnoea38 reports
arthralgia36 reports
anxiety35 reports
amnesia33 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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

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, g

Frequently Asked Questions

What is KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY used for?

KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY contains BENZOCAINE. It is a gel taken dental. Consult your doctor for specific uses.

Is KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY a controlled substance?

KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY is not classified as a controlled substance by the DEA.

What is the generic name for KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY?

The generic name for KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY is BENZOCAINE. There are 12 other brand versions of BENZOCAINE.

What is the NDC code for KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY 200 mg/g?

The NDC (National Drug Code) for KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY 200 mg/g is 25047-754, listed by DMG AMERICA, LLC.