GINGICAINE GEL- gingicaine gel banana flavor gel 
Gingi-Pak a Division of the Belport

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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GingiCaine Gel, Banana

Active ingredient

Active ingredients

Inactive ingredient

Inactive ingredient

Precautions

Precautions

Consult a doctor promptly

Consult a doctor promptly

Allergy Alert and Contraindication

ContraindicationsAllergy alert002

Purpose

Purpose

Keep out of reach of children

Keep out of reach of children

Dosage and Administration

Dosage and Administration001Dosage and Administration002

Indications and Uses

IndicationUses

Avoid excessive heat

Avoid excessive heat

Warnings

Warnings

GingiCaine Gel Banana label

Jar Label

GingiCaine Gel Banana-Hakusui

GingiCaine Gel Banana-Hakusui

GINGICAINE GEL 
gingicaine gel banana flavor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-035
Route of AdministrationORAL, DENTAL, PERIODONTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 260 mg
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 520 mg
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) 20 mg
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10129-035-031 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/06/1993
2NDC:10129-035-056 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/06/1993
3NDC:10129-035-011 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/07/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/06/1993
Labeler - Gingi-Pak a Division of the Belport (008480121)

Revised: 12/2021
Document Id: d2abd1a4-1bed-7d2d-e053-2995a90aed9f
Set id: 62857d06-a829-4efa-e053-2991aa0a6d15
Version: 3
Effective Time: 20211208
 
Gingi-Pak a Division of the Belport