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Natural Product Number (NPN):

00481122

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Hurricaine® Topical Anesthetic Gel

Licence holder:

Beutlich L.P.

Dosage Form:

Gel

Recommended route of administration:

Topical

Recommended use or purpose:

Topical anesthetic gel for mucosal application.

Risk Information:

Cautions and Warnings 

For professional use. Keep out of reach of children. For external use only. Caution: Not for injection. Patients with a known history of hypersensitivity to benzocaine should not use Hurricaine® Topical Anesthetic. Avoid contact with the eyes; if this happens, rinse thoroughly with water. Discontinue use and consult a health care practitioner if irritation develops. Stop use and consult a health care practitioner if the following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue coloured skin as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. Use smallest amount possible to achieve desired result. Do not use if allergic to benzocaine or any other ingredient in the product. Use with caution in children or consult a healthcare practitioner prior to use for children less than two years of age.

Known Adverse Reactions 

Patients with a known history of hypersensitivity to benzocaine should not use Hurricaine Topical Anesthetic. Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
Benzocaine	20.0 % (w/w)

List of non-medicinal ingredients:

• Mint Flavour
• Pina Colada Flavor
• Polyethylene glycol 3350
• Polyethylene glycol 400
• Sodium Saccharin
• Strawberry flavour
• Watermelon flavour
• Wild cherry

Date of licensing:

2008-11-26

Revised date of licence:

2017-02-03