Pac-Dent Top Gel by Pac-Dent International, Inc.
Dosage form: gel
Ingredients: BENZOCAINE 200mg in 1g
Labeler: Pac-Dent International, Inc.
NDC Code: 68983-002
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
For oral mucosa 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 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.
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 #40, blue #1, green #3 as a color additive.
|PAC-DENT TOP GEL
|Labeler - Pac-Dent International, Inc. (073253994)|
Medically reviewed on Dec 14, 2017
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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