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  5. Label Information: Lollicaine Pina Colada

FDA Label for Lollicaine Pina Colada

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?

Lollicaine Pina Colada Product Label

The following document was submitted to the FDA by the labeler of this product Centrix, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Benzocaine 20%


Purpose



Oral Anesthetic


Use



LolliCaine is a flavored topical anesthetic gel featuring rapid onset, no systemic absorption and a 15 minute duration. LolliCaine is packaged in a 1-oz. jar.

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



Use appropriate applicator and apply gel to mucosa or gingival soft tissue. Wait one minute or until tissue feels numb before starting needle injection or other procedure. 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?



CENTRIX INCORPORATED
770 River Road, Shelton CT 06484 USA
Toll Free (USA): (800) 235-5862
Tel: (203) 929-5582 • Fax: (203) 929-6804
www.centrixdental.com


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