{"contraindications":["4. CONTRAINDICATIONS Should not be used with individuals with a known sensitivity to benzocaine or PABA."],"description":["7. DESCRIPTION Flavored 20% benzocaine gel for topical mucosa anesthesia"],"dosage_and_administration":["2. DOSAGE AND ADMINISTRATION ❖ Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle. ❖ Tightly re-cap the jar after each use."],"dosage_forms_and_strengths":["3. DOSAGE FORMS AND STRENGTH Each gram of 20% Benzocaine Gel contains between 180-220 mg benzocaine in a flavored base."],"effective_time":"20180904","how_supplied":["8. HOW SUPPLIED/STORAGE AND HANDLING 20% benzocaine gel is supplied in multiple use containers Store between 59°-86°F (15°-30°C). Protect from freezing."],"id":"a43d1c49-5d68-4811-bdd6-16eaeeb46e2f","indications_and_usage":["1. INDICATIONS AND 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 intra- oral radiographs."],"openfda":{},"overdosage":["6. OVERDOSAGE In case of overdose, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 34g Jar Label - Cherry Topical Anesthetic Gel 20% Benzocaine Cherry REF: 2731001 CHERRY Quala ® DENTAL PRODUCTS NET CONTENTS: 1 oz (34g) Rx Only NDC 43128-021-30 PRINCIPAL DISPLAY PANEL - 34g Jar Label - Cherry","PRINCIPAL DISPLAY PANEL - 34g Jar Label - Mint Topical Anesthetic Gel 20% Benzocaine Mint REF: 2731002 MINT Quala ® DENTAL PRODUCTS NET CONTENTS: 1 oz (34g) Rx Only NDC 43128-023-30 PRINCIPAL DISPLAY PANEL - 34g Jar Label - Mint","PRINCIPAL DISPLAY PANEL - 34g Jar Label - Piña Colada Topical Anesthetic Gel 20% Benzocaine Piña Colada REF: 2731004 PIÑA COLADA Quala ® DENTAL PRODUCTS NET CONTENTS: 1 oz (34g) Rx Only NDC 43128-024-30 PRINCIPAL DISPLAY PANEL - 34g Jar Label - Piña Colada","PRINCIPAL DISPLAY PANEL - 34g Jar Label - Bubble Gum Topical Anesthetic Gel 20% Benzocaine Bubble Gum REF: 2731005 BUBBLE GUM Quala ® DENTAL PRODUCTS NET CONTENTS: 1 oz (34g) Rx Only NDC 43128-022-30 PRINCIPAL DISPLAY PANEL - 34g Jar Label - Bubble Gum","PRINCIPAL DISPLAY PANEL - 34g Jar Label - Strawberry Topical Anesthetic Gel 20% Benzocaine Strawberry REF: 2731006 STRAWBERRY Quala ® DENTAL PRODUCTS NET CONTENTS: 1 oz (34g) Rx Only NDC 43128-020-30 PRINCIPAL DISPLAY PANEL - 34g Jar Label - Strawberry","PRINCIPAL DISPLAY PANEL - 34g Jar Label - Raspberry Topical Anesthetic Gel 20% Benzocaine Raspberry REF: 2731007 RASPBERRY Quala ® DENTAL PRODUCTS NET CONTENTS: 1 oz (34g) Rx Only NDC 43128-026-30 PRINCIPAL DISPLAY PANEL - 34g Jar Label - Raspberry"],"set_id":"9bc3dbbb-b54f-42d2-a019-a1bf6294ccbe","spl_product_data_elements":["Topical Anesthetic Benzocaine Benzocaine Benzocaine Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Water FD&C RED NO. 40 Topical Anesthetic Benzocaine Benzocaine Benzocaine Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Water D&C GREEN NO. 5 Topical Anesthetic Benzocaine Benzocaine Benzocaine Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Water Pina Colada Topical Anesthetic Benzocaine Benzocaine Benzocaine Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Water D&C RED NO. 28 Topical Anesthetic Benzocaine Benzocaine Benzocaine Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Water FD&C RED NO. 40 Topical Anesthetic Benzocaine Benzocaine Benzocaine Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Water FD&C RED NO. 40"],"spl_unclassified_section":["Gel – 1oz/34g 2731001 Cherry 2731002 Mint 2731004 Pina Colada 2731005 Bubble Gum 2731006 Strawberry 2731007 Raspberry For dental use only Rx only","For more information call NDC at 1-800-929-4232 Manufactured for NDC Nashville, TN 37217 Made in the USA 2731001DF, R1-120116"],"storage_and_handling":["Store between 59°-86°F (15°-30°C). Protect from freezing."],"version":"2","warnings_and_cautions":["5. WARNINGS AND PRECAUTIONS METHEMOGLOBINEMIA WARNING Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if the patient 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 ❖ Not for use in children under 2 years of age ❖ Keep out of reach of children ❖ For professional dental use only ❖ Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle"]}