Topical Anesthetic Dental Gel

benzocaine

Dosage Form: gel
Topical Anesthetic

Banana Flavor Gel

INGREDIENTS

Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and FD&C Red #40.

USUAL DOSAGE

For oral mucosal use only as directed by a dentist.

CAUTION

Contains FD&C Yellow #5 (tartrazine) which may cause an allergenic response. Federal law prohibits dispensing without a prescription.

Warning

Keep out of reach of children. Do not use on people with known allergies to benzocaine and PABA compounds.

Store at controlled room temperature 59-86°F (15-30°C).

MADE IN U.S.A.

Distributed by:

PATTERSON

DENTAL

Corporate Office

1031 Mendota Heights Road

Saint Paul, MN 55120

PATTERSON

DENTAL /

Montréal Québec

H3M 3E6

PRINCIPAL DISPLAY PANEL - 29.6 mL Label

PATTERSON

DENTAL

Topical Anesthetic

Banana Flavor Gel

Contains 20% Benzocaine

For Professional Use Only

Net Contents 1 fl oz (29.6 mL)

Reorder Number

089-9989

TOPICAL ANESTHETIC   BANANA benzocaine  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50227-2116 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g

Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 3350   POLYETHYLENE GLYCOL 400   SACCHARIN SODIUM   FD&C RED NO. 40

Product Characteristics Color      Score      Shape Size Flavor BANANA Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50227-2116-1 34 g In 1 JAR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	02/19/1963

Labeler - Patterson Dental (171843584)

Registrant - DSHealthcare (056296981)

Establishment
Name	Address	ID/FEI	Operations
DENTSPLY Caulk		083235549	MANUFACTURE

Revised: 05/2010Patterson Dental

More Topical Anesthetic Dental Gel resources

• Topical Anesthetic Dental Gel Side Effects (in more detail)
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