Lollicaine Topical Anesthetic Gel/liquid –

Lollicaine Topical Anesthetic Gel/liquid –
SPL v6
SPL
SPL Set ID 56ae3a84-6bca-4906-a03d-9d755e1fba3b
Route
DENTAL
Published
Effective Date 2025-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Peg-8 Peg-75 Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: pink Color: red Color: green Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-14

Description

Benzocaine 20%

Purpose

Oral Anesthetic


Medication Information

Purpose

Oral Anesthetic

Description

Benzocaine 20%

Use

For the temporary relief of occasional minor irritation and pain, associated with:

  • Sore mouth and throat
  • Ulcers
  • Minor dental procedures
  • Needle punctures
  • Minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Section 51945-4

Warnings

For external use only

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 any “caine” anesthetics, such as benzocaine, butacaine, procaine or tetracaine.

Sore Throat Warning:

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

Directions

Do not exceed recommended dosage.

Adults and children 2 years of age and older: Apply to affected area up to 4 times daily or as directed by 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
  • For teething
  • In children under 2 years of age

When using this product

Avoid contact with eyes

Ask a doctor before use

  • If pregnant or breastfeeding
Other Information

Store at 59° to 86º F (15º to 30º C)

Active Ingredients

Benzocaine 20%

Inactive Ingredients

Bubble Gum flavor contains:PEG-8, PEG-75, sodium saccharin

Cherry flavor contains:Cherry flavor, PEG-8, PEG-75, sodium saccharin

Mint flavor contains: Mint flavor, PEG-8, PEG-75, sodium saccharin

Pina Colada flavor contains:PEG-8, PEG-75, PinaColada flavor, sodium saccharin

Questions Or Comments?

800.235.5862 | centrixdental.com

CENTRIX INCORPORATED

770 River Road

Shelton, CT 06484 USA

Toll Free (USA): 800.235.5862

CENTRIXDENTAL.COM

Keep Out of the Reach of Children


Structured Label Content

Use

For the temporary relief of occasional minor irritation and pain, associated with:

  • Sore mouth and throat
  • Ulcers
  • Minor dental procedures
  • Needle punctures
  • Minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Section 51945-4 (51945-4)

Purpose

Oral Anesthetic

Warnings

For external use only

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 any “caine” anesthetics, such as benzocaine, butacaine, procaine or tetracaine.

Sore Throat Warning:

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

Directions

Do not exceed recommended dosage.

Adults and children 2 years of age and older: Apply to affected area up to 4 times daily or as directed by 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
  • For teething
  • In children under 2 years of age

When using this product

Avoid contact with eyes

Ask a doctor before use

  • If pregnant or breastfeeding
Other Information (Other information)

Store at 59° to 86º F (15º to 30º C)

Active Ingredients (Active ingredients)

Benzocaine 20%

Inactive Ingredients (Inactive ingredients)

Bubble Gum flavor contains:PEG-8, PEG-75, sodium saccharin

Cherry flavor contains:Cherry flavor, PEG-8, PEG-75, sodium saccharin

Mint flavor contains: Mint flavor, PEG-8, PEG-75, sodium saccharin

Pina Colada flavor contains:PEG-8, PEG-75, PinaColada flavor, sodium saccharin

Questions Or Comments? (Questions or comments?)

800.235.5862 | centrixdental.com

CENTRIX INCORPORATED

770 River Road

Shelton, CT 06484 USA

Toll Free (USA): 800.235.5862

CENTRIXDENTAL.COM

Keep Out of the Reach of Children (Keep out of the reach of children)


Advanced Ingredient Data


Raw Label Data

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