GINGICAINE GEL, PINA COLADA- gingicaine gel, pina colada 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, Pina Colada

Active Ingredients

Active Ingredients

Inactive Ingredients

Inactive Ingredients

Precautions

Precautions

Warnings

Warnings

Consult a doctor promptly

Consult a doctor promptly

Allergy Alert and Contraindication

Allergy AlertContraindications

Purpose

Purpose

Keep out of reach of children

Keep out of reach of children

Dosage and Adminstration

Dosage and Adminstration001Dosage and Adminstration002

Indications and Use

IndicationsUses

Avoid excessive heat

Avoid excessive heat

GingiCaine Gel, Pina Colada label

Jar Label

GINGICAINE GEL, PINA COLADA 
gingicaine gel, pina colada flavor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-033
Route of AdministrationDENTAL, ORAL, 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
Colororange (Pina Colada flavor) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10129-033-011 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/06/1993
2NDC:10129-033-056 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/06/1993
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: d2bb2e64-8fb9-62a4-e053-2995a90a1889
Set id: 6284e1fe-be33-69bf-e053-2991aa0a90ab
Version: 2
Effective Time: 20211209
 
Gingi-Pak a Division of the Belport