FDA records indicate that there are no current recalls for this drug.
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Ultracare Anesthetic Pina Colada Recall
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Questions & Answers
Side Effects & Adverse Reactions
- if tamper-evident seal is broken. Store at room temperature.
- For external use only.
Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
- if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting
- if sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens.
- avoid contact with eyes.
Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Do not exceed recommended dosage.
- if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting
- if sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
for the temporary relief of occasional minor irritation and pain, associated with:
- minor dental procedures
- sore mouth and throat
- minor injury of the gums
- canker sores
- minor irritation of the mouth or gums caused by dentures or orthodontic appliances.
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Ultracare Anesthetic Pina Colada Manufacturers
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Ultradent Products, Inc.
Ultracare Anesthetic Pina Colada | Ultradent Products, Inc.
Adults and children 2 years of age and older Apply (a thin film) to affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily as directed by a dentist or doctor. Children under 12 years of age Should be supervised in the use of this product. Children under 2 years of age Consult a dentist or a doctor.
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