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Oral B Instant Pain Relief

Dosage form: gel
Ingredients: Benzocaine 0.2mL in 1mL
Labeler: Health-Tech, Inc.
NDC Code: 48871-008

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.

Drug Facts

Active Ingredient

Benzocaine 20%

Purpose

Oral anesthetic

Uses

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

  • toothache
  • sore gums
  • canker sores
  • braces
  • minor dental procedures
  • dentures

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
  • Avoid contact with eyes
  • Do not exceed recommended dosage
  • Do not use for more than 7 days unless directed by a doctor/dentist

Stop use and ask a doctor if:
  • sore mouth symptoms do not improve in 7 days
  • Irritation, pain or redness persist or worsens
  • Swelling, pain or fever develops

Directions:
  • Remove cap-, squeeze gel onto applicator
  • Adults and children 2 years of age and older, apply to the affected area 4 times per day or as directed by a doctor/dentist
  • Children under 2 years of age; consult a doctor/dentist
For Denture wearers
  • Remove Dentures
  • Apply thin layer to affected area
  • Do not reinsert dental work until irritation is relieved
  • Rinse mouth well before reinserting dentures

Other information:
  • Store between 200 to 250 C (680 to 770 F) Do not refrigerate
  • Do not purcahse if package has been opened

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

MM27

Oral B pain gel blister

MM28

Oral B shipper label

MM29

ORAL B INSTANT PAIN RELIEF  
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48871-008
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (benzocaine) Benzocaine0.2 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
Glycerin 
methylparaben 
Polyethylene glycol 
Polyethylene glycol 400 
Polyethylene Glycol 600 
Saccharin Sodium 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
Product Characteristics
Colorgreen (FD and C Green 5) Score    
ShapeSize
FlavorMINT (Scope Original Mint Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:48871-008-0112 CARTON (CARTON) in 1 BOX
16 BLISTER PACK (BLISTER) in 1 CARTON
13 TUBE (TUBE) 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/FEIOperations
Health-Tech, Inc.084007889manufacture

Revised: 05/2010
Document Id: 0ef7f255-aca0-4237-aa21-267780aca1d1
Set id: 04f67d13-d0fa-409c-94bb-0f0e780bc812
Version: 3
Effective Time: 20100528
 
Health-Tech, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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