OPAHL- benzocaine gel 
Dharma Research, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Benzocaine, 20%

Purpose

Oral anesthetic

Uses

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

Warnings

Allergy alert Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "-caine" anesthetics.

Do not use

this product for more than 7 days unless directed by a dentist or doctor.  If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly.

Do not

exceed recommended dosage

Keep out of reach of children

If more than used for pain is accidentially swallowed, get medical help or contact a Poison Control center right away.

Directions

Other Information

Store at room temperature 59-86°F (15-30°C). Protect from freezing and heat.

Inactive Ingredients

FD&C Red #40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol, Water

Opahl

Oral Anesthetic Gel Concord Grape

with Vitamin E and Xylitol

Gluten Free

1.12 oz (32 g)

Manufactured by Dharma Research, Inc., 5220 NW 72nd Ave, Unit 15, Miami, FL 33166

1-877-833-3725

www.dharmaresearch.com

NDC: 53045-102-30

20131101 102 Benzocaine Concord Grape

OPAHL 
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53045-102
Route of Administration ORAL, DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 6.4 g  in 32 g
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53045-102-30 32 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 11/02/2013
Labeler - Dharma Research, Inc. (078444642)
Registrant - Dharma Research, Inc. (078444642)
Establishment
Name Address ID/FEI Business Operations
Dharma Research, Inc. 078444642 manufacture(53045-102)

Revised: 11/2013
Document Id: 4320cd62-0107-4aec-9ec1-ab24e87fa181
Set id: b72ceb88-4a98-4f01-bd9d-5ff8b91c6a23
Version: 2
Effective Time: 20131104
 
Dharma Research, Inc.