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  5. Label Information: Defend

FDA Label for Defend

View Indications, Usage & Precautions

Table of Contents

    1. ​ACTIVE INGREDIENTS (IN EACH GRAM)​
    2. ​PURPOSE
    3. ​USE
    4. ​WARNINGS
    5. ​KEEP OUT OF REACH OF CHILDREN.
    6. ​DIRECTIONS​
    7. ​OTHER INFORMATION
    8. ​INACTIVE INGREDIENTS​
    9. ​QUESTIONS OR COMMENTS?
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Defend Product Label

The following document was submitted to the FDA by the labeler of this product Mydent International. 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 Ingredients (In Each Gram)​



Benzocaine 200 mg


​Purpose



Oral Anesthetic


​Use



For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.


​Warnings



  • ​Allergy Alert:​ Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
  • ​Do not use​ for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
  • ​When using this product​ Avoid contact with eyes. If contact occurs, flush with water.
  • ​Stop use and consult a health care practitioner​ if the following symptoms appear: weakness, confusion, headhache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
  • ​Do no exceed recommended dosage.​ If more than used for pain is accidentally swalled, get medical help or contact a Poison Control Center immediately.
  • ​If pregnant or breast feeding,​ ask a health professional before use.

​Keep Out Of Reach Of Children.



Keep out of reach of children.


​Directions​



Apply only amount needed to the oral mucosa to prevent or relieve pain.


​Other Information



Store at 59° - 86°F (15 - 30°C).

Protect from freezing.


​Inactive Ingredients​



Flavoring, PEG 3350, PEG 400, sodium saccharine. May contain yellow #5 (tartrazine), yellow #6, red #3, red #40, blue #1, green #3 as a color additive.


​Questions Or Comments?



1-800-275-0020


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