1oz Pc Liquid

1oz Pc Liquid
SPL v25
SPL
SPL Set ID f70fa3fc-cd65-4a80-9efd-129e98fd3998
Routes
DENTAL ORAL PERIODONTAL
Published
Effective Date 2015-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 1986-08-15

Description

Benzocaine 20%

Purpose

Oral Anesthetic


Medication Information

Purpose

Oral Anesthetic

Description

Benzocaine 20%

Uses

for 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.  Gargle, swish around in the mouth, or 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 0283-1886-31

HURRICAINE®

Topical Anesthetic LIQUID

20% Benzocaine Oral Anesthetic

PINA COLADA

Manufactured for:

Beutlich® Pharmaceuticals, LLC

Bunnell, FL 32110

Made in the USA

1 fl. 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 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

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 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.  Gargle, swish around in the mouth, or 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 0283-1886-31

HURRICAINE®

Topical Anesthetic LIQUID

20% Benzocaine Oral Anesthetic

PINA COLADA

Manufactured for:

Beutlich® Pharmaceuticals, LLC

Bunnell, FL 32110

Made in the USA

1 fl. 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 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

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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