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NDC 10129-0035-01 GingiCaine Gel 200 mg/1 Details

GingiCaine Gel 200 mg/1

GingiCaine Gel is a DENTAL; ORAL; PERIODONTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Gingi-Pak a Division of the Belport. The primary component is BENZOCAINE.

Product Information

NDC	10129-0035
Product ID	10129-035_d2abd1a4-1bed-7d2d-e053-2995a90aed9f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	GingiCaine Gel
Proprietary Name Suffix	n/a
Non-Proprietary Name	GingiCaine Gel Banana flavor
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	DENTAL; ORAL; PERIODONTAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	BENZOCAINE
Labeler Name	Gingi-Pak a Division of the Belport
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10129-0035-01 (10129003501)

Pricing Information	N/A
NDC Package Code	10129-035-01
Billing NDC	10129003501
Package	1 GEL in 1 BOTTLE, PLASTIC (10129-035-01)
Marketing Start Date	2001-05-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 62857d06-a829-4efa-e053-2991aa0a6d15 Details

Active ingredient

Inactive ingredient

Precautions

Consult a doctor promptly

Allergy Alert and Contraindication

Purpose

Keep out of reach of children

Dosage and Administration

Indications and Uses

Avoid excessive heat

Warnings

GingiCaine Gel Banana label

GingiCaine Gel Banana-Hakusui

INGREDIENTS AND APPEARANCE

GINGICAINE GEL

gingicaine gel banana flavor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-035
Route of Administration	ORAL, DENTAL, 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	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-035-03	1 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/06/1993
2	NDC:10129-035-05	6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/06/1993
3	NDC:10129-035-01	1 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/07/2001

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	07/06/1993

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