FDA.reportPublic FDA data

Iolite

Manufacturer
Dharma Research, Inc.
Effective date
2023-10-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:56:37

Label at a glance#

ProductIolite
Active ingredientBENZOCAINE
Label structure9 sections

Indications and uses

For the temporary relief of pain associated with canker sores and minor dental procedures.

Dosage and administration

Adults and children 2 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product Children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine, 20%

Purpose

OTC - PURPOSE SECTION

Oral anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain associated with canker sores and minor dental procedures.

Warnings

WARNINGS SECTION

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 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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "-caine" anesthetics.

Do not use this product for more than 7 days unless directed by a dentist or a doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly.

Do not exceed recommended dosage.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: Consult a dentist or doctor.

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD&C Red #40, FD& C Blue #1, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol

Iolite

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oral Anesthetic Gel Raspberry Jam

with Vitamin E and Xylitol

Gluten Free

1.12 oz (32 g)

Manufactured by Dharma Research, Inc., 5220 NW 72nd Ave, Unit 15, Miami, FL 33166

1-877-833-3725

www.dharmaresearch.com

20201013_135_RevD20201013_135_RevD

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
53045-135-30Iolite32 g in 1 BOTTLEGEL323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53045-135IOLITE (BENZOCAINE) GEL [DHARMA RESEARCH, INC.]3Current NDC, Legacy NDC, 1 package rows20231011_db763237-2910-45b9-be72-da092edc951b.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53045-13553045-135-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XYLITOLVCQ006KQ1EIACT

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
IoliteBENZOCAINEDharma Research, Inc.db763237-2910-45b9-be72-da092edc951b2023-10-10WarningsExact identifier
ndc (package): 53045-135-30
ndc (product): 53045-135
ndc11 (package): 53045013530
spl id: 4284221e-bcf8-4840-9bfc-18c8bf0716f6
spl set id: db763237-2910-45b9-be72-da092edc951b

Reported adverse events (FAERS/openFDA)#

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