Hurricaine Gel
FDA Label NDC 0283-0998

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Beutlich Pharmaceuticals Llc for the product Hurricaine (NDC 0283-0998). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingedient, purpose, uses, warnings, stop use and ask doctor if, when using this product, keep out of reach of children., adverse reactions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingedient

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

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

Stop Use And Ask 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
  • sore mouth symptoms do not improve in 7 days, or if 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.

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.

Directions

  • do not exceed recommend 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: 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 Ingredient

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

NDC 0283-0998-31

HURRICAINE®

Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic

FRESH MINT

Manufactured for:

Beutlich®

Pharmaceuticals, LLC

Bunnell, FL

www.beutlich.com

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