FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active Ingredients (In Each Gram):
For oral mucosal use. Use only as directed by dentist. For the temporary relief of pain due to minor dental procedures.
- 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.
Apply only amount needed to the oral mucosa to prevent or relieve pain.
Store at 59°-86°F (15°-30°C). Protect from freezing.
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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