Active Ingredients (In Each Gram)
Benzocaine 200mg
Burkhart Topical Anesthetic Gel
FDA Label NDC 43498-310
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Burkhart Dental Supply Inc for the product Burkhart Topical Anesthetic (NDC 43498-310). 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 ingredients (in each gram), purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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, 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 breastfeeding, ask a health professional before use.
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.
Questions Of Comments?
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www.burkhartdental.com
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