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NDC 10129-0715-03 GingiCaine gel, Cherry 200 mg/1 Details

GingiCaine gel, Cherry 200 mg/1

GingiCaine gel, Cherry 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	10129-0715
Product ID	10129-715_d2bb569e-6ed0-1f93-e053-2995a90ab6df
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, Cherry
Proprietary Name Suffix	n/a
Non-Proprietary Name	Gingicaine Gel, Cherry 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 10129-0715-03 (10129071503)

Pricing Information	N/A
NDC Package Code	10129-715-03
Billing NDC	10129071503
Package	1 GEL in 1 BOTTLE, PLASTIC (10129-715-03)
Marketing Start Date	1999-06-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6274d92e-c4e9-34fd-e053-2991aa0ae604 Details

Active ingredients

Inactive ingredients

Precautions

Warnings

Consult a doctor promptly

Allergy alert and Contraindications

Purpose

Keep out of reach of Children

Dosage and Administration

Indications and Uses

Avoid excessive heat

GingiCaine Gel Cherry Label

INGREDIENTS AND APPEARANCE

GINGICAINE GEL, CHERRY

gingicaine gel, cherry flavor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-715
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
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)	20 mg
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	520 mg

Product Characteristics
Color	red (Cherry flavor)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-715-03	1 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/21/1999
2	NDC:10129-715-05	6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/21/1999

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	06/21/1999

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

Revised: 12/2021

Document Id: d2bb569e-6ed0-1f93-e053-2995a90ab6df

Set id: 6274d92e-c4e9-34fd-e053-2991aa0ae604

Version: 2

Effective Time: 20211209