HURRICAINE TOPICAL ANESTHETIC- benzocaine gel
Beutlich Pharmaceuticals LLC
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.
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for the temporary relief of occasional minor irritation and pain, associated with:
Allergy alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butaine, benzocaine or other "caine" anesthetics.
If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.
adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.
children under 12 years of age: should be supervised in the use of the product
children under 2 years of age: consult a dentist or doctor
HURRICAINE
TOPICAL ANESTHETIC
benzocaine gel |
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Labeler - Beutlich Pharmaceuticals LLC (005209325) |
Registrant - Beutlich Pharmaceuticals LLC (005209325) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Dental Technologies | 148312838 | manufacture(0283-0998) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Speciality Pharma Manufacturing | 013957125 | manufacture(0283-0998) |