FDA Label for Budpak Oral Maximum Strength
View Indications, Usage & Precautions
Budpak Oral Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Budpak Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient
Benzocaine 20%
Otc - Purpose
Purpose
Anesthetic
Indications & Usage
Uses
for the temporary relief of pain associated with:
- toothache
- canker sores
- cold sores
- fever blisters
- minor dental procedures
Warnings
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
Otc - When Using
When using this product
- avoid contact with the eyes
- do not exceed recommended dosage
Otc - Stop Use
Stop using this product 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
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
adults and children 2 years of age and older:
- break seal on tube
- apply to the affected area up to 4 times daily or as directed by a dentist or a 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
Other Information
- store at room temperature.
- Lot. No and Exp. Date: see crimp of tube.
PRINCIPAL DISPLAY PANEL
ORAL MAXIMUM STRENGTH PAIN RELIEF GEL
Benzocaine 20%
Anesthetic
NET WT 0.5 OZ (14 g)
Inactive Ingredient
Inactive Ingredients
Ammonium Glycyrrhizate, Polyethylene glycol, Saccharin sodium, Sorbic acid, Flavor
Package Label.Principal Display Panel
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