ORAL B INSTANT PAIN RELIEF  - benzocaine gel 
Health-Tech, Inc.

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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Drug Facts

Active Ingredient

Benzocaine 20%

Purpose

Oral anesthetic

Uses

Temporarily relieves pain associated with the following mouth and gum irritations:

Warnings

Allergy Alert: do not use this pr9oduct if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other :caine" anesthetics.

When using this product

Stop use and ask a doctor if:

Directions:

For Denture wearers

Other information:

Inactive Ingredients

Benzyl alcohol, carbomer 974P, FD and C green 5, Flavor, glycerin, Methylparaben, Polyethylene glycol, PEG 400, PEG 600, Sodium Saccharin

Oral B Pain gel label

MM27oral B tooth pain gel label

Oral B pain gel blister

MM28oral B tooth pain gel blister

Oral B shipper label

MM29Oral B shipper label

ORAL B INSTANT PAIN RELIEF  
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48871-008
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) Benzocaine0.2 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol (UNII: LKG8494WBH)  
Glycerin (UNII: PDC6A3C0OX)  
methylparaben (UNII: A2I8C7HI9T)  
Polyethylene glycol (UNII: 3WJQ0SDW1A)  
Polyethylene glycol 400 (UNII: B697894SGQ)  
Polyethylene Glycol 600 (UNII: NL4J9F21N9)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: K61870Z308)  
Product Characteristics
Colorgreen (FD and C Green 5) Score    
ShapeSize
FlavorMINT (Scope Original Mint Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48871-008-0112 in 1 BOX
16 in 1 CARTON
13 in 1 BLISTER PACK
16 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33306/31/2010
Labeler - Health-Tech, Inc. (084007889)
Establishment
NameAddressID/FEIBusiness Operations
Health-Tech, Inc.084007889manufacture

Revised: 5/2010
Document Id: 0ef7f255-aca0-4237-aa21-267780aca1d1
Set id: 04f67d13-d0fa-409c-94bb-0f0e780bc812
Version: 3
Effective Time: 20100528
 
Health-Tech, Inc.