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NDC 10129-0033-01 GingiCaine Gel, Pina Colada 200 mg/1 Details

GingiCaine Gel, Pina Colada 200 mg/1

GingiCaine Gel, Pina Colada 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	10129-0033
Product ID	10129-033_d2bb2e64-8fb9-62a4-e053-2995a90a1889
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, Pina Colada
Proprietary Name Suffix	n/a
Non-Proprietary Name	GingiCaine Gel, Pina Colada 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 10129-0033-01 (10129003301)

Pricing Information	N/A
NDC Package Code	10129-033-01
Billing NDC	10129003301
Package	1 GEL in 1 BOTTLE, PLASTIC (10129-033-01)
Marketing Start Date	1993-07-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6284e1fe-be33-69bf-e053-2991aa0a90ab Details

Active Ingredients

Inactive Ingredients

Precautions

Warnings

Consult a doctor promptly

Allergy Alert and Contraindication

Purpose

Keep out of reach of children

Dosage and Adminstration

Indications and Use

Avoid excessive heat

GingiCaine Gel, Pina Colada label

INGREDIENTS AND APPEARANCE

GINGICAINE GEL, PINA COLADA

gingicaine gel, pina colada flavor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-033
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	orange (Pina Colada flavor)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-033-01	1 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/06/1993
2	NDC:10129-033-05	6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/06/1993

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: d2bb2e64-8fb9-62a4-e053-2995a90a1889

Set id: 6284e1fe-be33-69bf-e053-2991aa0a90ab

Version: 2

Effective Time: 20211209