GINGICAINE GEL, MINT JULEP- gingicaine gel, mint julep flabvor 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, Mint Julep

Active Ingredient

Inactive Ingredient

Precautions

Consult a doctor promptly

Allergy Alert and Contraindications

Allergy Alert Contraindications

Purpose

Keep out of reach of children

Dosage and Administration

Dosage and Administration001 Dosage and Administration002

Indications and Uses

Indications Uses

Avoid excessive heat

Warnings

Mint Julep Label

Jar label

GINGICAINE GEL, MINT JULEP
gingicaine gel, mint julep flabvor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-063
Route of Administration	DENTAL, ORAL, PERIODONTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)	260 mg
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	520 mg
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)	20 mg

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Mint Julep)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-063-03	1 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/13/1998
2	NDC:10129-063-05	6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/13/1998

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	07/13/1998

Labeler - Gingi-Pak a Division of the Belport (008480121)

Revised: 12/2021

Document Id: d2aa34f8-d139-b3a6-e053-2a95a90aab6d

Set id: 6285fe10-08ba-8044-e053-2991aa0a8e8b

Version: 2

Effective Time: 20211208

Gingi-Pak a Division of the Belport