OPAHL- benzocaine spray, metered 
Dharma Research, inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

Dosage

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

Directions

Other Information

Inactive ingredients

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

Label

Entire Label

OPAHL 
benzocaine spray, metered
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53045-125
Route of AdministrationORAL, TOPICAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE12 g  in 60 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ALCOHOL (UNII: 3K9958V90M)  
PROPANE (UNII: T75W9911L6)  
ISOBUTANE (UNII: BXR49TP611)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-125-6060 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2013
Labeler - Dharma Research, inc. (078444642)
Registrant - Dharma Research, inc. (078444642)
Establishment
NameAddressID/FEIBusiness Operations
Dharma Research, inc.078444642manufacture(53045-125)

Revised: 1/2013
Document Id: c2ad7bd9-78c9-40d9-9d3f-8e3c56de6036
Set id: 2b4a6b21-396a-4b07-b1b9-751643cb5821
Version: 1
Effective Time: 20130101
 
Dharma Research, inc.