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Mark 3 by Cargus International, Inc.

Medically reviewed on Feb 28, 2018

Dosage form: gel
Ingredients: BENZOCAINE 6.4g in 32g
Labeler: Cargus International, Inc.
NDC Code: 61509-103

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 accidentially 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

Strawberry

Gluten Free

with Vitamin E and Xylitol

NDC 61509-103-32

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:61509-103
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
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61509-103-3232 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/28/2014
Labeler - Cargus International, Inc. (096191093)
Establishment
NameAddressID/FEIOperations
Dharma Research, Inc.078444642manufacture(61509-103)

 
Cargus International, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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