Hurricaine One Spray
FDA Label NDC 0283-1024

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 One (NDC 0283-1024). 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 ingredients, 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 Ingredients

Lidocaine 4%

Benzalkonium Chloride 0.13%

Purpose

Topical Anesthetic/Analgesic

Topical First-Aid Antiseptic

Uses

Uses:

  • For the temporary relief of pain
  • First aid to help protect against infection in minor cuts, scrapes, and burns

Warnings

  • For external use only. Do not use In the eyes or apply over large areas of the body, particularly over raw sur1aces or blistered areas. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
  • If condition worsens, or If symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not use longer than 1 week unless directed by a doctor.
  • Flammable. Keep away from fire or flame.

Do Not Use

Do not Use

  • if foil pouch has been previously opened
  • 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 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: Clean the affected area. Spray a small amount of this product on the area 1 to 3 times dally. May be covered wtth a sterile bandage. If bandaged, let dry first.

    children under 2 years of age: do not use, consult a physician

Other Information

  • store at 15-30 °C (59-86 °F)

Inactive Ingredients

Polyethylene glycol, Ethanol

Questions Or Comments?

1-800-238-4582

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

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