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 Bubble Gum

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: 53045-100-30

20131101 100 Benzocaine Bubble Gum

OPAHL 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53045-100
Route of AdministrationORAL, DENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE6.4 g  in 32 g
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
POLYETHYLENE GLYCOL 3350 
POLYETHYLENE GLYCOL 400 
SACCHARIN SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
XYLITOL 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-100-3032 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/02/2013
Labeler - Dharma Research, Inc. (078444642)
Registrant - Dharma Research, Inc. (078444642)
Establishment
NameAddressID/FEIBusiness Operations
Dharma Research, Inc.078444642manufacture(53045-100)

Revised: 11/2013
Document Id: f5e4326e-617a-430c-bd41-f3602cc3fd08
Set id: fedc2da3-ccf0-494c-8650-45934a203f7f
Version: 6
Effective Time: 20131105
 
Dharma Research, Inc.