Hurricaine Gel
FDA Label NDC 0283-0622

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 0283-0622). 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 ingredient, purpose, uses, warnings, do not use, when using this product, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 tray seal is broken or missing
  • if cap is missing 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?

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