IOLITE-S- benzocaine spray

Iolite-S by

Drug Labeling and Warnings

Iolite-S by is a Otc medication manufactured, distributed, or labeled by Dharma Research, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzocaine 20%

Purpose

Oral anesthetic

Uses

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

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 use 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 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 doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persist or worsens, or if swelling, rash, or fever develops, see your dentist or doctor promptly.

• For teething
• In children under 2 years of age

Do not use near fire or flame. Flammable.

Do not exceed recommended dosage.

Avoid spraying in the eyes.

Keep out of reach of children. If more than used for pain is accidentially swallowed, get medical help or contact a Poison Control Center right away.

Directions

Shake well before use. Firmly insert extension tube into spray can valve and ensure it fits securely in the actuator opening. Position the extension tube 1-2 inches from the affected area. Press 1/2 second (press and immediately release the actuator).

• Adults and children 12 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: do not use.

Inactive Ingredients

Ethyl alcohol, Flavor, Isobutane (propellant), Polyethylene glycol, Propane (propellant), Saccharine sodium.

Other Information

Store at room temperature 59-86°F (15-30°C).

SPL UNCLASSIFIED SECTION

Manufactured by:

Dharma Research, Inc.

www.dharmaresearch.com

5220 N.W. 72 Avenue, Unit 15

Miami, FL 33166

1-877-833-3725

SPL UNCLASSIFIED SECTION

NDC: 53045-127-60

Iolite-S

Oral Anesthetic Spray

Gluten Free

Made in USA

2 fl. oz. (60 mL)

Fresh Spearmint

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IOLITE-S 
benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53045-127
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPANE (UNII: T75W9911L6)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53045-127-60	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/04/2021

Labeler - Dharma Research, Inc. (078444642)

Registrant - Dharma Research, Inc. (078444642)

Establishment
Name	Address	ID/FEI	Business Operations
Dharma Research, Inc.		078444642	manufacture(53045-127)