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Opahl Gel

Generic Name: benzocaine
Dosage Form: dental gel

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.

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 Green #3, FD&C Yellow #5.

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

OPAHL 
benzocaine gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53045-104
Route of Administration ORAL, TOPICAL, DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 6.4 g  in 32 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400  
POLYETHYLENE GLYCOL 3350  
SACCHARIN SODIUM  
XYLITOL  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
Product Characteristics
Color      Score     
Shape Size
Flavor MINT (Mint Parfait) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:53045-104-30 32 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 Operations
Dharma Research, inc. 078444642 manufacture(53045-104)
Revised: 01/2013
 
Dharma Research, inc.



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