VISTACAINE TOPICAL ANESTHETIC- benzocaine gel 
Inter-Med, 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 Ingredients (in each gram)

Benzocaine 200 mg

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

​Keep Out of Reach of Children.

Keep Out of Reach of Children.

​Directions

Apply only amount needed to the oral mucosa to prevent or relieve pain.

​Other Information

Store at 59º -86°F (15 - 30°C).

Protect from freezing.

​Inactive ingredients

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

Questions or comments?

1-262-636-9755

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VISTACAINE TOPICAL ANESTHETIC 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64522-002
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)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64522-002-3030 g in 1 JAR; Type 0: Not a Combination Product02/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/01/2018
Labeler - Inter-Med, INC. (036623932)

Revised: 1/2022
Document Id: d658b63c-d2bc-1438-e053-2a95a90a9f87
Set id: 34a99087-3423-4e85-93e5-89d2f504528b
Version: 2
Effective Time: 20220124
 
Inter-Med, INC.