Hurricaine Spray
FDA Label NDC 0283-0610

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 0283-0610). 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, when using this product, stop use and ask doctor if, 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 temporary gag reflex suppression
  • for the temporary relief of occasional minor irritation and pain associated with sore mouth and throat

Warnings

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

When Using This Product

  • avoid contact with eyes

Stop Use And Ask Doctor If

  • sore throat is severe, persists for more than 2 days, is accompanied or followed be 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

Keep Out Of Reach Of Children.

If more than used for pain is accidently 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: 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

  • store at 15-30 °C (59-86 °F)
  • do not use if foil pouch has been previously opened

Inactive Ingredients

flavor, polyethylene goycol, sodium saccharin

Questions Or Comments?

1-800-238-4582

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

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