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Mark 3

Cargus International, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Benzocaine, 20%

Purpose

Oral Anesthetic

Mark 3 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

  • 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, FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No. 5, 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

Mark 3

Oral Anesthetic Gel

Pina Colada

Gluten Free

with Vitamin E and Xylitol

NDC 61509-104-32

Net Wt. 1.12 oz. (32 g)

Distributed by Mark 3, 135 North Rt. 9W, Congers, NY 10920

Made in USA

Mark 3

Mark 3

Benzocaine GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61509-104
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 6.4 g

Inactive Ingredients

Ingredient Name Strength
FD&C RED NO. 40
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
FD&C YELLOW NO. 5
POLYETHYLENE GLYCOL 3350
polyethylene glycol 400
saccharin sodium
.ALPHA.-TOCOPHEROL ACETATE
Xylitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61509-104-32 32 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2014-03-03


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