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  5. Label Information: Benzo-jel

FDA Label for Benzo-jel

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

Benzo-jel Product Label

The following document was submitted to the FDA by the labeler of this product Henry Schein 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 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 contat occurs, flush with water.
  • ​Stop use and consult a health care practitioner​ if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rae disorder, which may appear up to 2 hours after use.
  • ​Do not exceed recommended dosage.​ If more than used for pain is accidentally swallowed, 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).

Prorect from freezing.


​Inactive Ingredients



​flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain blue #1, green #5, red #3, red #28, red #40, yellow #5 (tartrazine), as a color additive.


Questions Or Comments?



1-800-472-4346


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