Lollicaine Cherry Gel, Dentifrice
FDA Label NDC 60640-9000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Centrix, Inc. for the product Lollicaine Cherry (NDC 60640-9000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings, do not use, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzocaine 20%

Purpose

Oral Anesthetic

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

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.

Do Not Use

  • for teething
  • in children under 2 years of age

    • When using this product

    avoid contact with eyes

    If pregnant or breast-feeding,

    ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact Poison Control Center right away.

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

Other Information

Store at 59° to 86° F (15° to 30° C)

Inactive Ingredients

Blue 1*, flavor, PEG-8, PEG-75, Red 3*, Red 33*, Red 40*, sodium saccharin, Yellow 10*

*contains one or more of these ingredients.

Questions Or Comments?

Contact

Centrix, Inc.,

770 River Rd, Shelton, CT 06484

Toll Free (800) 235-5862

TEL (203) 929-5582

FAX (203) 929-6804

www.centrixdental.com

* Please review the disclaimer below.