Drugplain

PureLife Topical Anesthetic 200 mg/g

Benzocaine · GEL · PureLife Dental

No Recall History
Plain English

PureLife Topical Anesthetic is a gel containing benzocaine at 200 mg/g, taken dental. Manufactured by PureLife Dental.

Key Facts

Brand Name
PureLife Topical Anesthetic
Generic Name
Benzocaine
NDC Code (Product)
68987-005
Manufacturer
PureLife Dental
Strength
200 mg/g
Dosage Form
GEL
Route
DENTAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
07/01/2013

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

Dosage & Administration

Directions 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 the 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 heart rate 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 procaine, butacaine, benzocaine or other "caine" anesthetics. Do not use for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age When using this product Avoid contact with eyes. If contact occurs, flush with water. Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast feeding, ask a phys

Frequently Asked Questions

What is PureLife Topical Anesthetic used for?

PureLife Topical Anesthetic contains Benzocaine. It is a gel taken dental. Consult your doctor for specific uses.

Is PureLife Topical Anesthetic a controlled substance?

PureLife Topical Anesthetic is not classified as a controlled substance by the DEA.

What is the generic name for PureLife Topical Anesthetic?

The generic name for PureLife Topical Anesthetic is Benzocaine. There are 12 other brand versions of Benzocaine.

What is the NDC code for PureLife Topical Anesthetic 200 mg/g?

The NDC (National Drug Code) for PureLife Topical Anesthetic 200 mg/g is 68987-005, listed by PureLife Dental.