Ipana 20% Benzocaine Topical

Manufacturer
Maxill Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:26:39

Label at a glance#

ProductIpana 20% Benzocaine Topical
Active ingredientBENZOCAINE
Label structure10 sections

Dosage and administration

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

Storage and handling

Store at 59°-86°F (15°-30°C). Protect from freezing.

Label contents#

Full prescribing information#

Active Ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 200mg

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

​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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

STORAGE AND HANDLING SECTION

Store at 59°-86°F (15°-30°C). Protect from freezing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

flavoring, PEG 3350, PEG 400, sodium saccharin. May contain yellow #5 (tartrazine), yellow #6, red #3, red #40, blue #1, green #3 as a color additive.

Questions?

OTC - QUESTIONS SECTION

1-855-462-9455 or 1-519-631-7370

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LB.ipana-Topical-Gel-Wrap_US.jpgLB.ipana-Topical-Gel-Wrap_US.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN9
238910benzocaine 0.2 MG/MG Oral GelSCD9
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69510-358-30Ipana 20% Benzocaine Topical28 g in 1 JARGEL289

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69510-35869510-358-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.f36bb9bd-e9bc-4f35-a388-e0ffadbce6ab2025-12-17WarningsExact identifier
ndc (package): 69510-358-30
ndc (product): 69510-358
ndc11 (package): 69510035830
spl id: 462b952f-b7ca-5c54-e063-6294a90abd61
spl set id: f36bb9bd-e9bc-4f35-a388-e0ffadbce6ab

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.