HURRICAINE TOPICAL ANESTHETIC GEL - benzocaine gel 
Beutlich LP, Pharmaceuticals

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Drug Facts

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

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

Stop use and ask a doctor

• if sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, swelling, nausea or vomiting
• if sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens
  

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

• 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:  consult a dentist or doctor

Other information

• Do not use if imprinted seal under cap is broken or missing
• store at 20°- 25°C (68°- 77°F)
  

Inactive ingredient

flavor, polyethylene glycol, sodium saccharin

Questions or comments?

1-800-238-8542

M-Th: 7:30 a.m.-5 p.m., F: 7:30 a.m.-4 p.m. CT

Principal Display Panel

NDC 0283-0871-31

HURRICAINE®

Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic

ORIGIAL WILD CHERRY

Manufactured for:

Beutlich® LP,

Pharmaceuticals

Waukegan, IL 60085

Made in the USA

1 oz.

HURRICAINE  TOPICAL ANESTHETIC GEL benzocaine   gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0283-0871 Route of Administration ORAL, DENTAL, PERIODONTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Aminobenzoic Acid) Benzocaine 200 mg  in 1 g

Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 400   Polyethylene Glycol 3350   Saccharin Sodium

Product Characteristics Color brown (amber) Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0283-0871-31 28.4 g In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/15/1971

Labeler - Beutlich LP, Pharmaceuticals (005209325)

Revised: 09/2009Beutlich LP, Pharmaceuticals