Hurricaine Gel - Cherry 1oz

Hurricaine Gel - Cherry 1oz
SPL v27
SPL
SPL Set ID 1f3d68f6-afd6-42e7-b3e5-210228c8e7de
Routes
ORAL DENTAL PERIODONTAL
Published
Effective Date 2015-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Polyethylene Glycol 400 Polyethylene Glycol 3350 Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 1971-08-15

Description

Benzocaine 20%

Purpose

Oral Anesthetic


Medication Information

Purpose

Oral Anesthetic

Description

Benzocaine 20%

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.

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

Active Ingredient

Benzocaine 20%

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

Inactive Ingredients

flavor, polyethylene glycol, sodium saccharin

Questions Or Comments?

1-800-238-8542

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

Principal Display Panel

NDC 0283-0871-31

HURRICAINE®

Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic

ORIGINAL WILD CHERRY

Manufactured for:

Beutlich® Pharmaceuticals, LLC

Bunnell, FL 32110

1 oz.

When Using This Product
  • avoid contact with eyes

Stop Use and Ask A Doctor
  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by 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

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.


Structured Label Content

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
Purpose

Oral Anesthetic

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.

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

Active Ingredient (Active ingredient)

Benzocaine 20%

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

Inactive Ingredients (Inactive ingredients)

flavor, polyethylene glycol, sodium saccharin

Questions Or Comments? (Questions or comments?)

1-800-238-8542

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

Principal Display Panel

NDC 0283-0871-31

HURRICAINE®

Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic

ORIGINAL WILD CHERRY

Manufactured for:

Beutlich® Pharmaceuticals, LLC

Bunnell, FL 32110

1 oz.

When Using This Product (When using this product)
  • avoid contact with eyes

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by 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

Keep Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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