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  5. Label Information: Mark 3

FDA Label for Mark 3

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. DISTRIBUTED BY
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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



FD&C Red No. 40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine 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

Gluten Free

with Vitamin E and Xylitol

NDC 61509-103-32

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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