GINGICAINE FUSION- benzocaine 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 Fusion

Active Ingredient

Active ingredient

Purpose

Purpose

Allergy Alert

Allergy alter

Consult a doctor

Consult a doctor

Avoid Excessive heat

Avoid excessive heat

Caution

Caution

Contraindications

Contraindications

Directions for Use

Directions for use

Dosage & Administration

Dosage and Administration

Inactive Ingredients

Inactive ingredients

Indications

Indications

Keep out of reach of children

Keep out of reach of children

Overdosage

Overdose

Precautions

Precautions

Temper Evident Statement

Temper Evident Statement

Uses

Uses

Warnings

Warnings

Description

Description

Principal Display

Jar label_vanilla

Jar box_vanilla

Syringe_Vanilla

Jar label_strawberry

Jar box_strawberry

Sryringe_Strawberry

box package

GINGICAINE FUSION 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-041
Route of AdministrationTOPICAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 24 g  in 100 g
CANNABIDIOL (UNII: 19GBJ60SN5) 2 g  in 100 g
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 52 g  in 100 g
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) 2 g  in 100 g
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10129-041-0114 g in 1 JAR; Type 0: Not a Combination Product06/04/2021
2NDC:10129-041-2020 in 1 BOX06/04/2021
21.2 g in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/04/2021
GINGICAINE FUSION 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 24 g  in 100 g
CANNABIDIOL (UNII: 19GBJ60SN5) 2 g  in 100 g
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) 2 g  in 100 g
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 52 g  in 100 g
Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10129-040-0114 g in 1 JAR; Type 0: Not a Combination Product06/04/2021
2NDC:10129-040-2020 in 1 BOX06/04/2021
21.2 g in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/04/2021
Labeler - Gingi-Pak a Division of the Belport (008480121)
Registrant - Jeff Nichols (008480121)
Establishment
NameAddressID/FEIBusiness Operations
Gingi-Pak a Division of the Belport008480121manufacture(10129-040, 10129-041)

Revised: 12/2021
Document Id: d292edc9-652b-b62d-e053-2995a90a635c
Set id: a1f3c4d4-048c-7c3c-e053-2995a90a1b35
Version: 2
Effective Time: 20211207
 
Gingi-Pak a Division of the Belport