FDA Label for Lollicaine Pina Colada
View Indications, Usage & Precautions
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.
How Supplied
Topical Anesthetic Gel 20% Benzocaine
Store at 59°F - 86°F (15°C - 30°C)
BUBBLE GUM REF 360088 Contains 120 Lollipacks (.40g each)
CHERRY REF 360090 Contains 120 Lollipacks (.40g each)
MINT REF 360092 Contains 120 Lollipacks (.40g each)
PINA COLADA REF 360094 Contains 120 Lollipacks (.40g each)
Description
LolliCaine is a flavored topical anesthetic gel featuring rapid onset, no systemic absorption, and 15-minute duration. LolliCaine is packaged in single-dose LolliPacks for maximum asepsis and ease of use. LolliPacks are also ideal to give to patients for take-home, post- operative topical pain relief. Each LolliPackunit contains one unit dose of LolliCaine gel plus swab applicator.
Indications & Usage
Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intraoral radiographs.
Contraindications
Should not be used with individuals with a known sensitivity to benzocaine.
Warnings
Keep out of reach of children. For professional dental use only.
Precautions
Avoid prolonged periods of storage at higher temperatures, it may cause degradation products.
Adverse Reactions
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with benzocaine gel. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); mouth burning, irritation, redness, swelling, or tenderness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.
Ingredients
INGREDIENTS: Each gram of LolliCaine 20% benzocaine gel contains 200mg of benzocaine
U.S.P. in a water soluble base of P.E.G. 3350 U.S.P., P.E.G. 400 U.S.P., flavor, sodium sac- charin U.S.P. and (cherry)[FD&C Red #40) (mint)[FD&C green #5)
.
Other
Centrix Incorporated 770 River Road, Shelton, CT 06484 USA
Tel (203) 929-5582 Fax (203) 929-6804
Toll-Free (USA & Canada): (800) 235-5862
Bubble Gum Package Label
Cherry
Mint
Pina Colada
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