MARK 3- benzocaine gel gel

Mark 3 by

Drug Labeling and Warnings

Mark 3 by is a Otc medication manufactured, distributed, or labeled by Cargus International, Inc., Dharma Research, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

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

PRINCIPAL DISPLAY PANEL

Mark 3

Oral Anesthetic Gel

Pina Colada Dye Free

Gluten Free

with Vitamin E and Xylitol

NDC: 61509-107-32

Net Wt. 1.12 oz. (32 g)

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

Made in USA

INGREDIENTS AND APPEARANCE

MARK 3 
benzocaine gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61509-107
Route of Administration	ORAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	6.4 g  in 32 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61509-107-32	32 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/03/2014

Labeler - Cargus International, Inc. (096191093)

Establishment
Name	Address	ID/FEI	Business Operations
Dharma Research, Inc.		078444642	manufacture(61509-107)