OPAHL- benzocaine gel 
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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Ingredients

Each gram of Opahl 20% benzocaine gel contains 200mg of benzocaine USP, in a water soluble base of PEG 3350, PEG 400, Flavor, Sodium Saccharine USP, Tocopheryl Acetate, Xylitol, FD&C Red #40.

Usual Dosage

For oral mucosa. Use only as directed by a dentist

Warning

Keep out of reach of children. Store at controlled room temperature 59o to 86o F (15o - 30oC) Protect from freezing and heat.

Caution

Federal (USA) law prohibits dispensing without a prescription

Label

Entire Label

OPAHL 
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:53045-101
Route of AdministrationORAL, TOPICAL, DENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE6.4 g  in 32 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 3350 
SACCHARIN SODIUM 
XYLITOL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Tart) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53045-101-3032 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(53045-101)

Revised: 01/2013
Document Id: d39db0ea-1d1b-4465-95f4-a348a8b95a1d
Set id: c0d57395-53a9-43c8-8fbc-b5cce4979000
Version: 1
Effective Time: 20130116
 
Dharma Research, inc.