HURRICAINE ONE- topical anesthetic and antiseptic spray

HurriCaine One by

Drug Labeling and Warnings

HurriCaine One by is a Otc medication manufactured, distributed, or labeled by Beutlich Pharmaceuticals LLC, Beutlich Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

HURRICAINE ONE 
topical anesthetic and antiseptic spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0283-1024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	200 mg  in 1 g
ALCOHOL (UNII: 3K9958V90M)	758.7 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0283-1024-11	2 in 1 BOX	12/10/2025
1	NDC: 0283-1024-43	0.37 g in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 0283-1024-26	25 in 1 BOX	12/10/2025
2	NDC: 0283-1024-43	0.37 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/10/2025

Labeler - Beutlich Pharmaceuticals LLC (005209325)

Registrant - Beutlich Pharmaceuticals LLC (005209325)

Establishment
Name	Address	ID/FEI	Business Operations
Beutlich Pharmaceuticals, LLC		005209325	pack(0283-1024) , label(0283-1024)