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  5. Label Information: Hurricaine Topical Anesthetic Liquid

FDA Label for Hurricaine Topical Anesthetic Liquid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. STOP USE AND ASK A DOCTOR
    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. ADVERSE REACTIONS
    13. PRINCIPAL DISPLAY PANEL
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hurricaine Topical Anesthetic Liquid 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 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



Allergy alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.


Stop Use And Ask A Doctor



  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, swelling, nausea or vomiting
  • if sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens

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



  • do not exceed recommended dosage

    • adults and children 2 years of age and older: apply to the affected area.  Gargle, swish around in the mouth, or 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


Other Information



  • Do not use if imprinted seal under cap is broken or missing
  • 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


Adverse Reactions



Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.


Principal Display Panel



NDC 0283-0569-31

HURRICAINE®

Topical Anesthetic LIQUID

20% Benzocaine Oral Anesthetic

ORIGINAL WILD CHERRY

Manufactured for:

Beutlich® Pharmaceuticals, LLC

Bunnell, FL 32110

Made in the USA

1 fl. oz.


* Please review the disclaimer below.