Hurricaine Unit Dose Gel And Swab - Cherry

Hurricaine Unit Dose Gel And Swab - Cherry
SPL v26
SPL
SPL Set ID e628bd9f-99e5-4c71-ba8a-caa6c337de54
Routes
ORAL DENTAL PERIODONTAL
Published
Effective Date 2021-01-22
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 2021-01-31

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

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray, or blue colored skin (cyanosis)

• headache

• rapid heart rate

• shortness of breath

• dizziness or lightheadedness

• fatigue or lack of energy

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

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

Directions

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: do not use
Do Not Use

Do not use:

  • if the product film is punctured or damaged
  • for teething
  • in children under 2 years of age
Active Ingredient

Benzocaine 20%

Other Information
  • 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

HurriCaine Unit Dose Gel Wild Cherry 0.5g with Swab:  0283-0871-45

60ct HurriCaine Unit Dose Gel Wild Cherry 0.5g with Swab: 0283-0871-59

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.


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

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray, or blue colored skin (cyanosis)

• headache

• rapid heart rate

• shortness of breath

• dizziness or lightheadedness

• fatigue or lack of energy

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

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

Directions

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: do not use
Do Not Use (Do not use)

Do not use:

  • if the product film is punctured or damaged
  • for teething
  • in children under 2 years of age
Active Ingredient (Active ingredient)

Benzocaine 20%

Other Information (Other information)
  • 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

HurriCaine Unit Dose Gel Wild Cherry 0.5g with Swab:  0283-0871-45

60ct HurriCaine Unit Dose Gel Wild Cherry 0.5g with Swab: 0283-0871-59

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

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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