HURRICAINE TOPICAL ANESTHETIC- benzocaine spray
Beutlich Pharmaceuticals, LLC
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for the temporary relief of occasional minor irritation and pain, associated with:
Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy
Allergy alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Flammable. Do not use near fire or flame. Avoid smoking during use.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
When using this product
If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Directions:
adults and children 2 years of age and older: 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: do not use.
HURRICAINE
TOPICAL ANESTHETIC
benzocaine spray |
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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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Beutlich Pharmaceuticals, LLC | 005209325 | pack(0283-0679) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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TRI-PAC, INC. | 020844956 | manufacture(0283-0679) |