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Iolite by Dharma Research, Inc.

Medically reviewed on July 23, 2017

Dosage form: gel
Ingredients: Benzocaine 6.4g in 100g
Labeler: Dharma Research, Inc.
NDC Code: 53045-133

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Benzocaine, 20%

Purpose

Oral anesthetic

Uses

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

Warnings

Alergy 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
  • 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

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

Inactive Ingredients

FD&C Red #40, FD&C Yellow #5, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol

Iolite

Oral Anesthetic Gel Mango Frappe

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

IOLITE 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53045-133
Route of AdministrationORAL, DENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (BENZOCAINE) Benzocaine6.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 5 
POLYETHYLENE GLYCOL 3350 
POLYETHYLENE GLYCOL 400 
SACCHARIN SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
XYLITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorMANGOImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53045-133-3032 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/19/2017
Labeler - Dharma Research, Inc. (078444642)
Establishment
NameAddressID/FEIOperations
Dharma Research, Inc.078444642manufacture(53045-133)

 
Dharma Research, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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