Drugplain

Ipana 20% Benzocaine Topical 200 mg/g

Benzocaine · GEL · Maxill Inc.

1 Recall on Record
Plain English

Ipana 20% Benzocaine Topical is a gel containing benzocaine at 200 mg/g, taken dental. Manufactured by Maxill Inc..

Key Facts

Brand Name
Ipana 20% Benzocaine Topical
Generic Name
Benzocaine
NDC Code (Product)
69510-353
Manufacturer
Maxill Inc.
Strength
200 mg/g
Dosage Form
GEL
Route
DENTAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
08/01/2016

Recall History

1 Recall on Record
Class II11/14/2024

Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

TerminatedVoluntary: Firm initiated

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 Apply only amount needed to the oral mucosa to prevent or relieve pain.

Warnings

Warnings ​Allergy alert: ​Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics. ​Do not use ​for more than 7 days unless directed by a dentist or doctor. 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 dentist or doctor promptly. ​When using this product ​avoid contact with eyes. If contact occurs, flush with water. ​Stop use and consult a health care practitioner ​if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. ​Do not exceed recommended dosage. ​If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately. ​If pregnant or breastfeeding, ​ask a health professional before use.

Frequently Asked Questions

What is Ipana 20% Benzocaine Topical used for?

Ipana 20% Benzocaine Topical contains Benzocaine. It is a gel taken dental. Consult your doctor for specific uses.

Is Ipana 20% Benzocaine Topical a controlled substance?

Ipana 20% Benzocaine Topical is not classified as a controlled substance by the DEA.

What is the generic name for Ipana 20% Benzocaine Topical?

The generic name for Ipana 20% Benzocaine Topical is Benzocaine. There are 12 other brand versions of Benzocaine.

What is the NDC code for Ipana 20% Benzocaine Topical 200 mg/g?

The NDC (National Drug Code) for Ipana 20% Benzocaine Topical 200 mg/g is 69510-353, listed by Maxill Inc..