Mark 3
FDA Label NDC 61509-103

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cargus International, Inc. for the product Mark 3 (NDC 61509-103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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