Mint Gel 1oz

Mint Gel 1oz
SPL v45
SPL
SPL Set ID 723da3ae-3f1f-4962-920b-f2a30c8c3253
Routes
DENTAL PERIODONTAL
Published
Effective Date 2018-06-27
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: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 1998-09-15

Description

Benzocaine 20%

Purpose

Oral Anesthetic

Adverse Reactions

Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.


Medication Information

Purpose

Oral Anesthetic

Adverse Reactions

Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.

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, butaine, benzocaine or other "caine" anesthetics.

Directions
  • do not exceed recommend 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 Ingedient

Benzocaine 20%

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

Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.

Inactive Ingredient

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 0283-0998-31

HURRICAINE®

Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic

FRESH MINT

Manufactured for:

Beutlich®

Pharmaceuticals, LLC

Bunnell, FL

www.beutlich.com

When Using This Product
  • avoid contact with eyes
Stop Use and Ask 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
  • sore mouth symptoms do not improve in 7 days, or if 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, butaine, benzocaine or other "caine" anesthetics.

Directions
  • do not exceed recommend 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 Ingedient (Active ingedient)

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)
Adverse Reactions:

Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.

Inactive Ingredient (Inactive ingredient)

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 0283-0998-31

HURRICAINE®

Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic

FRESH MINT

Manufactured for:

Beutlich®

Pharmaceuticals, LLC

Bunnell, FL

www.beutlich.com

When Using This Product (When using this product)
  • avoid contact with eyes
Stop Use and Ask Doctor If (Stop use and ask 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
  • sore mouth symptoms do not improve in 7 days, or if 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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