ORAL B INSTANT PAIN RELIEF- benzocaine gel

Oral B Instant Pain Relief by

Drug Labeling and Warnings

Oral B Instant Pain Relief by is a Otc medication manufactured, distributed, or labeled by Health-Tech, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ORAL B INSTANT PAIN RELIEF  
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48871-008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5)	Benzocaine	0.2 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	green (FD and C Green 5)	Score
Shape		Size
Flavor	MINT (Scope Original Mint Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48871-008-01	12 in 1 BOX
1		6 in 1 CARTON
1		3 in 1 BLISTER PACK
1		6 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	06/31/2010

Labeler - Health-Tech, Inc. (084007889)

Establishment
Name	Address	ID/FEI	Business Operations
Health-Tech, Inc.		084007889	manufacture