IOLITE- benzocaine gel 
Dharma Research, Inc.

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Active Ingredient

Benzocaine, 20%

Purpose

Oral anesthetic

Uses

For the temporary relief of 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 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.

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

Other Information

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

Inactive Ingredients

Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol

Iolite

Oral Anesthetic Cherry Tart Dye Free

With Vitamin E and Xylitol

Gluten Free

1.12 oz (32 g)

Manufactured by: Dharma Research, Inc., 5520 NW 72nd Avenue, Unit 15, Miami, FL, 33166

1-877-833-3725

www.dharmaresearch.com

20201013_138_RevD

IOLITE 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53045-138
Route of AdministrationORAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-138-3032 g in 1 BOTTLE; Type 0: Not a Combination Product07/23/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02207/23/2017
Labeler - Dharma Research, Inc. (078444642)
Establishment
NameAddressID/FEIBusiness Operations
Dharma Research, Inc.078444642manufacture(53045-138)

Revised: 10/2023
Document Id: 8e01b193-fdc4-4ea8-94a9-7f2b30fe806b
Set id: 414cbec9-94e2-4bca-908b-1e79f8db0b27
Version: 3
Effective Time: 20231010
 
Dharma Research, Inc.