MIDWAY SELECT TOPICAL ANESTHETIC- benzocaine gel 
Midway Dental Supply, LLC

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 Ingredients

Benzocaine 200 mg ( in each g)

Purpose

Oral Anesthetic

Use

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to 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 immediate medical attention if you or a child in your care develops:

​Allergy alert: ​Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. 

​Do not use

​When using this product ​avoid contact with eyes. If contact occurs, flush with water.

​Do not exceed recommended dosage. ​If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. 

​If pregnant or breastfeeding, ​ask a health professional before use.

​Keep out of reach of children.

Directions

Other Information

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

Inactive Ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green# 5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

Questions or comments?

800.474.6111

midwaydental.com

LB.Midway_Topical Wrap.jpg

MIDWAY SELECT TOPICAL ANESTHETIC 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72304-010
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72304-010-3030 g in 1 JAR; Type 0: Not a Combination Product06/01/201801/27/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/01/201801/27/2025
Labeler - Midway Dental Supply, LLC (102354446)
Registrant - Midway Dental Supply, LLC (102354446)
Establishment
NameAddressID/FEIBusiness Operations
Midway Dental Supply, LLC102354446manufacture(72304-010)

Revised: 2/2023
Document Id: ae42f967-4320-44db-8d86-3c8112f28202
Set id: 87da80b5-1ed9-4667-8e58-e01ca8f0819b
Version: 3
Effective Time: 20230206
 
Midway Dental Supply, LLC