OPAHL- benzocaine spray, metered

Opahl by

Drug Labeling and Warnings

Opahl by is a Prescription medication manufactured, distributed, or labeled by Dharma Research, inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzocaine 20%......................................................Oral Anesthetic

Uses

For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.

Warnings

• Keep out of reach of children
• If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
• Do not use if you have a history of allergy to local anesthetic such a procaine, butacaine, benzocaine or other "caine" anesthetics.
• Flammable. Do not use near fire or flame. Avoid smoking during use.
• Avoid spraying in eyes.

Dosage

A single metered spray dispenses 50mg of Opahl-S Topical Anesthetic.

Directions

• Do not exceed recommended dosage
• Firmly insert extension tube into spray can valve and ensure it fits securely into the actuator opening
• position the extension tube 1-2 inches from the affected area.
• Spray 1/2 second (press and immediately release the actuator)
• Anesthesia is accomplished in approximately 20 seconds.

Other Information

• Do not store at room temperature above 49oC (120oF)
• For professional use only. Federal US Law prohibits dispensing without a prescription

Inactive ingredients

Denatured Alcohol, Flavor, Polyethylene Glycol, Sodium Saccharin, Hydrocarbon Propellant (Isobutane and Propane)

Label

INGREDIENTS AND APPEARANCE

OPAHL 
benzocaine spray, metered

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 53045-125
Route of Administration	ORAL, TOPICAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	12 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ALCOHOL (UNII: 3K9958V90M)
PROPANE (UNII: T75W9911L6)
ISOBUTANE (UNII: BXR49TP611)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53045-125-60	60 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2013

Labeler - Dharma Research, inc. (078444642)

Registrant - Dharma Research, inc. (078444642)

Establishment
Name	Address	ID/FEI	Business Operations
Dharma Research, inc.		078444642	manufacture(53045-125)