Oral Gel
Budpak Inc.
Drug Facts
FULL PRESCRIBING INFORMATION
Active ingredient
Active Ingredient
Purpose
Purpose
Uses
Uses
- toothache
- canker sores
- cold sores
- fever blisters
- minor dental procedures
Warnings
- do not use for more than 7 days unless directed by a dentist or a doctor
- if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics
When using this product
- avoid contact with the eyes
- do not exceed recommended dosage
Stop using and ask a doctor
- sore mouth symptoms do not improve in 7 days
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
Keep this and all drugs out of reach of childrenDirections
- cut open tip of tube
- apply to the affected area up to 4 times daily or as directed by a dentist or doctor
- children under 12 years of age should be supervised in the use of the product
- children under 2 years of age, there is no recommended dosage except under the advice and supervision of a dentist or a doctor
Other information
- store at room temperature
- Lot No. and Exp. Date: see box or see crimp of tube
Inactive Ingredients
Product Information
|
Product Type
|
Human otc drug label |
Item Code (Source)
|
NDC:27293-012 |
Route of Administration
|
TOPICAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
Ingredient Name
|
Basis of Strength
|
Strength
|
BENZOCAINE Benzocaine |
|
20 g
|
Packaging
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
1 |
NDC:27293-012-14 |
14 in 1 TUBE |
|
|
2 |
NDC:27293-012-01 |
1 in 1 BOX |
|
|
Marketing Information
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
part |
part356 |
2010-02-01 |
|
|
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!