ORAL ANALGESIC MAXIMUM STRENGTH- benzocaine gel

Oral Analgesic by

Drug Labeling and Warnings

Oral Analgesic by is a Otc medication manufactured, distributed, or labeled by LIFElabs, a Division of Atico International USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Oral Analgesic (Maximum Strength)

Active Ingredient

Benzocaine 20%

PURPOSE

Purpose

Oral pain reliever

Uses

temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters,  minor irritation of the mouth and gums caused by dentures or orthodontic appliances

WARNINGS

Warnings

for temporary use only until a dentist can be consulted

Allergy alert:

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

INDICATIONS & USAGE

When using this product

• do not use more than directed
• do not use for more than 7 days unless directed by a doctor/dentist
• do not use more than 4 times in a 24 hour period unless directed by a doctor/dentist
  

STOP USE

Stop use and ask a doctor if

• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens
• swelling, rash, or fever develops
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In cases of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• remove cap and cut tip of tube on score mark
• adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. use up to 4 times daily or as directed by a doctor or dentist.
• children under 12 year of age: should be supervised in the use of this product
• children under 2 years of age: ask a doctor/dentist
  

STORAGE AND HANDLING

Other information

• store at 15o to 25o (50o to 77oF)
• This preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist can be consulted. Do not use continuously
• Lot No. and Exp. Date: see box or see crimp of tube
  

INACTIVE INGREDIENT

Inactive Ingredients

d-sorbitol solution, glycerin, peppermint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium

QUESTIONS

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORAL ANALGESIC  MAXIMUM STRENGTH
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51852-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Glycerin (UNII: PDC6A3C0OX)
Peppermint (UNII: V95R5KMY2B)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Polyethylene Glycol 4000 (UNII: 4R4HFI6D95)
Saccharin Sodium (UNII: SB8ZUX40TY)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51852-101-01	1 in 1 CARTON
1		11.9 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/01/2010

Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)