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  5. Label Information: Hurricaine Topical Anesthetic

FDA Label for Hurricaine Topical Anesthetic

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?
    12. PRINCIPAL DISPLAY PANEL

Hurricaine Topical Anesthetic Product Label

The following document was submitted to the FDA by the labeler of this product Beutlich Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Benzocaine 20%


Purpose



Oral Anesthetic


Uses



for the temporary relief of occasional minor irritation and pain, associated with:

  • canker sores
  • sore mouth and throat
  • minor injury of the mouth and gums
  • minor dental procedures
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings



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.

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.


Do Not Use



Do not use:

  • if the product film is punctured or damaged
    • for teething
      • in children under 2 years of age

When Using This Product



  • 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.


Directions



Directions:

Do not exceed recommended dosage.

  • 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: do not use

Other Information



  • store at 20°-25° C (68°-77° F)


Inactive Ingredients



  • flavor, polyethylene glycol, sodium saccharin

Questions Or Comments?



1-800-238-8542

M-F: 8:00 a.m. - 4:30 p.m. ET


Principal Display Panel



HurriCaine Unit Dose Gel Wild Cherry 0.5g with Swab:  0283-0871-45

60ct HurriCaine Unit Dose Gel Wild Cherry 0.5g with Swab: 0283-0871-59


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