Pc Gel 1oz

Pc Gel 1oz
SPL v25
SPL
SPL Set ID fef1f48c-e89d-4b75-9ba0-b1b068daf582
Routes
DENTAL ORAL PERIODONTAL
Published
Effective Date 2018-06-26
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: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 1986-08-15

Description

Benzocaine 20%

Purpose

Oral Anesthetic

Storage and Handling

store at 20°-25°C (68°-77°F)


Medication Information

Purpose

Oral Anesthetic

Storage and Handling

  • store at 20°-25°C (68°-77°F)
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 imprinted seal under cap is broken or missing

• for teething

• in children under 2 years of age      

Active Ingredient

Benzocaine 20%

Inactive Ingredients

flavor, polyethylene glycol, sodium saccharin

Questions Or Comments?

1-800-238-8542



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

Principal Display Panel

NDC 0283-0886-31



HURRICAINE®



Topical Anesthetic GEL



20% Benzocaine Oral Anesthetic



PINA COLADA



Manufactured for:

Beutlich® Pharmaceuticals LLC

Bunnell, FL 32110

Made in the USA

1 oz.

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.


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

• if imprinted seal under cap is broken or missing

• for teething

• in children under 2 years of age      

Active Ingredient (Active ingredient)

Benzocaine 20%

Inactive Ingredients (Inactive ingredients)

flavor, polyethylene glycol, sodium saccharin

Storage and Handling

  • store at 20°-25°C (68°-77°F)
Questions Or Comments? (Questions or comments?)

1-800-238-8542



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

Principal Display Panel

NDC 0283-0886-31



HURRICAINE®



Topical Anesthetic GEL



20% Benzocaine Oral Anesthetic



PINA COLADA



Manufactured for:

Beutlich® Pharmaceuticals LLC

Bunnell, FL 32110

Made in the USA

1 oz.

When Using This Product (When using this product)

When using this product: avoid contact with eyes

Keep Out of Reach of Children (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.


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Raw Label Data

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