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  5. Label Information: Patterson Dental Topical Anesthetic

FDA Label for Patterson Dental Topical Anesthetic

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH GRAM):
    2. PURPOSE:
    3. USE:
    4. WARNINGS:
    5. DOSAGE & ADMINISTRATION
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS:
    8. OTHER INFORMATION:
    9. INACTIVE INGREDIENTS:
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Patterson Dental Topical Anesthetic Product Label

The following document was submitted to the FDA by the labeler of this product Patterson Dental. 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 200mg


Purpose:



Oral Anesthetic


Use:



For oral mucosal use. 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 healthcare 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 rare 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. 

Dosage & Administration



Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.


Otc - 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 saccharin. May contain yellow #5 (tartrazine), yellow #6, red #3, red #40, blue #1, green #3 as a color additive.


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