{"adverse_reactions":["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; pale, gray or blue colored skin as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. 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."],"contraindications":["CONTRAINDICATIONS Should not be used with individuals with a known sensitivity to benzocaine."],"description":["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, postoperative topical pain relief. Each LolliPack unit contains one unit dose of LolliCaine ® gel plus swab applicator. 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 saccharin U.S.P. and (cherry) [FD&C Red #40) (mint) [FD&C green #3)"],"effective_time":"20190318","how_supplied":["HOW SUPPLIED Lollicaine Lollipacks Topical Anesthetic Gel 20% Benzocaine is supplied as: Flavor NDC Label Reference BUBBLE GUM NDC:60640-0088-1 REF 360088 Contains 120 Lollipacks (.40g each) CHERRY NDC:60640-0090-1 REF 360090 Contains 120 Lollipacks (.40g each) MINT NDC:60640-0092-1 REF 360092 Contains 120 Lollipacks (.40g each) PINA COLADA NDC:60640-0094-1 REF 360094 Contains 120 Lollipacks (.40g each) STORAGE: Store at 59°F - 86°F (15°C - 30°C) Avoid prolonged periods of storage at higher temperatures, it may cause degradation products. Distributed by: CENTRIX INCORPORATED 770 River Road, Shelton CT 06484 USA Tel: (203) 929-5582 Fax: (203) 929-6804 Toll Free (USA & Canada): (800) 235-5862 www.centrixdental.com @2016 Centrix, Inc. Revised (Modifié) 01/2016 012007 REV I"],"how_supplied_table":["
Flavor NDC Label Reference
BUBBLE GUM NDC:60640-0088-1 REF 360088 Contains 120 Lollipacks (.40g each)
CHERRY NDC:60640-0090-1 REF 360090 Contains 120 Lollipacks (.40g each)
MINT NDC:60640-0092-1 REF 360092 Contains 120 Lollipacks (.40g each)
PINA COLADA NDC:60640-0094-1 REF 360094 Contains 120 Lollipacks (.40g each)
"],"id":"8fd61c3c-49f8-4178-b8ed-ff890a9aee7c","indications_and_usage":["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. LolliCaine ® is for oral mucosal use only as directed by dentist. TO USE: Remove one LolliCaine unit from the 8 unittray. Slowly peel back the lid, exposing the cotton swab applicator and unit dose well of LolliCaine gel. Dip swab applicator and apply gel to mucosa or gingival soft tissue. Wait 1 minute or until patient feels numb before starting needle injection or other procedure. After treatment, patient may be given one or more Lollipacks to treat post-operative pain or discomfort."],"openfda":{},"package_label_principal_display_panel":["Bubble Gum Package label Bubble Gum Flavor","Cherry Cherry Flavor","Mint Mint Flavor","Pina Colada Pina Collada"],"set_id":"ead1406b-1a00-4a4f-9fa8-831001eb8d9a","spl_product_data_elements":["LolliCaine Cherry Benzocaine Benzocaine Benzocaine POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM FD&C RED NO. 40 LolliCaine Mint Benzocaine Benzocaine Benzocaine POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM FD&C GREEN NO. 3 LolliCaine Bubble Gum Benzocaine Benzocaine Benzocaine POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM FD&C RED NO. 40 FD&C GREEN NO. 3 LolliCaine Pina Colada Benzocaine Benzocaine Benzocaine POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM FD&C RED NO. 40 FD&C GREEN NO. 3 Pina Coloda"],"version":"2","warnings_and_cautions":["WARNINGS AND PRECAUTIONS Do not use on patients with a known sensitivity to benzocaine or p-aminobenzoate compounds. Do not use on children under the age of 2 without the consent of a doctor as safety and efficacy have not been confirmed. Keep out of reach of children. Methemoglobinemai Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase efficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobinemia levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Lolicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. DRUG INTERACTIONS Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: Class Examples Nitrates/Nitrites Nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics Benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine Antineoplastic agents Cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea Antibiotics Dapsone, sulfonamides, nitrofurantoin, paraaminosalicylic acid Antimalarials Chloroquinone, primaquine Anticonvulsants Phenytoin, sodium valproate, phenobarbital Other drugs Acetaminophen. Metoclopramide, sulfa drugs (i.e. sulfasalazine), quinine PATIENT COUNSELING INFORMATION Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis) ; headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue."],"warnings_and_cautions_table":["
Class Examples
Nitrates/Nitrites Nitroglycerin, nitroprusside, nitric oxide, nitrous oxide
Local anesthetics Benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine
Antineoplastic agents Cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea
Antibiotics Dapsone, sulfonamides, nitrofurantoin, paraaminosalicylic acid
Antimalarials Chloroquinone, primaquine
Anticonvulsants Phenytoin, sodium valproate, phenobarbital
Other drugs Acetaminophen. Metoclopramide, sulfa drugs (i.e. sulfasalazine), quinine
"]}