FDA Label for Mark 3
View Indications, Usage & Precautions
Mark 3 Product Label
The following document was submitted to the FDA by the labeler of this product Cargus International, 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.
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.
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
- Adults and children 12 years of age and older: Apply to the affected area. Use 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: Consult a dentist or doctor.
Other Information
Store at room temperature 59 - 86°F (15 - 30°C). Protect from freezing and heat.
Inactive Ingredients
Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharin sodium, Tocopheryl acetate, Xylitol
Distributed By
Mark 3, 135 North Rt. 9W, Congers, NY, 10920
1-888-732-2913
Package Label.Principal Display Panel
Mark 3
Oral Anesthetic Gel
Strawberry Dye Free
Gluten Free
with Vitamin E and Xylitol
NDC 61509-109-32
Net Wt. 1.12 oz. (32 g)
Distributed by Mark 3, 135 North Rt. 9W, Congers, NY 10920
Made in USA
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