MARK 3- benzocaine gel 
Cargus International, Inc.

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.

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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

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

Other Information

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

Inactive Ingredients

FD&C Red No. 3, FD&C Blue No. 1, 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

Grape

Gluten Free

with Vitamin E and Xylitol

NDC 61509-106-32

Net Wt. 1.12 oz. (32 g)

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

Made in USA

20140303 106 Grape

MARK 3 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61509-106
Route of AdministrationORAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6.4 g  in 32 g
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
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
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61509-106-3232 g in 1 BOTTLE; Type 0: Not a Combination Product03/23/2021
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/FEIBusiness Operations
Dharma Research, Inc.078444642manufacture(61509-106)

Revised: 3/2021
Document Id: bd33dee8-f8ce-c670-e053-2995a90af3f8
Set id: fd94b002-c263-4872-8fc4-c484b07133c4
Version: 2
Effective Time: 20210323
 
Cargus International, Inc.