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Mark 3 by Cargus International, Inc.

Medically reviewed on March 5, 2018

Dosage form: gel
Ingredients: BENZOCAINE 6.4g in 32g
Labeler: Cargus International, Inc.
NDC Code: 61509-105

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

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 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 accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • 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 the 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 No. 40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol

Distributed by

Mark 3, 135 North Rt. 9W, Congers, NY 10920

1-888-732-2913

Mark 3

Oral Anesthetic Gel

Bubble Gum

Gluten Free

with Vitamin E and Xylitol

NDC 61509-105-32

Net Wt. 1.12 oz. (32 g)

Distributed by Mark 3, 135 North Rt. 9W, Congers, NY 10920

Made in USA

MARK 3 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61509-105
Route of AdministrationORAL, DENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE6.4 g  in 32 g
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
POLYETHYLENE GLYCOL 3350 
POLYETHYLENE GLYCOL 400 
SACCHARIN SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
XYLITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61509-105-3232 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/03/2014
Labeler - Cargus International, Inc. (096191093)
Establishment
NameAddressID/FEIOperations
Dharma Research, Inc.078444642manufacture(61509-105)

 
Cargus International, 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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