{"contraindications":["4. CONTRAINDICATIONS Do not use onindividuals with a known sensitivity to benzocaine or PABA."],"description":["7. DESCRIPTION Flavored 20% benzocaine gel or liquid for topical mucosal 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 STRENGTHS Each gram of Topex Topical Anesthetic Gel contains between 180-220 mg benzocaine in a flavored base."],"effective_time":"20251211","id":"aebb646a-c435-4892-954d-45ad150fdaac","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 intraoral radiographs. Apply as required."],"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 - Cherry 34 Gram Cherry 1 oz","PRINCIPAL DISPLAY PANEL - Mint 34 gram Mint 1 oz","PRINCIPAL DISPLAY PANEL - Pina Colada 34 gram P Colada 1 oz","PRINCIPAL DISPLAY PANEL - Bubble Num 34 gram B Num 1 oz","PRINCIPAL DISPLAY PANEL - Strawberry 34 gram Strawberry 1 oz","PRINCIPAL DISPLAY PANEL - Razzberry 34 gram Razzberry 1 oz","PRINCIPAL DISPLAY PANEL - Cherry 100 gram Cherry 100 gram","PRINCIPAL DISPLAY PANEL - Mint 100 gram Mint 100 g","PRINCIPAL DISPLAY PANEL - Pina Colada 100 gram P Colada 100 g","PRINCIPAL DISPLAY PANEL - Bubble Num 100 gram B Num 100 g"],"set_id":"87083cc6-fedc-4676-84e1-3134f690dfa9","spl_product_data_elements":["Topex Pina Colada Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM POLYETHYLENE GLYCOL 3350 Pina Colada Topex Cherry Benzocaine BENZOCAINE BENZOCAINE FD&C RED NO. 40 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM WATER POLYETHYLENE GLYCOL 400 Topex Mint Benzocaine BENZOCAINE BENZOCAINE D&C GREEN NO. 5 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM WATER PEPPERMINT OIL POLYETHYLENE GLYCOL 3350 Topex Bubble Gum Benzocaine BENZOCAINE BENZOCAINE D&C RED NO. 28 WATER POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM Topex Strawberry Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 WATER SACCHARIN SODIUM FD&C RED NO. 40 Topex Raspberry Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM FD&C RED NO. 40 D&C RED NO. 28 FD&C BLUE NO. 1 WATER Topex Cherry Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM WATER FD&C RED NO. 40 Topex Mint Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM WATER PEPPERMINT OIL D&C GREEN NO. 5 Topex Pina Colada Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 Pina Colada Topex Bubble Gum Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM WATER POLYETHYLENE GLYCOL 400 D&C RED NO. 28"],"spl_unclassified_section":["DIRECTIONS FOR USE Gel – 1oz/30mL AD31001 Cherry AD31002 Mint AD31004 Pina Colada AD31005 Bubble-Num AD31006 Strawberry AD31007 Razzberry Gel – 100g jar AD31064 Cherry AD31964 Mint AD31067 Pina Colada AD31068 Bubble-Num For dental use only. Rx only.","MANUFACTURED FOR Sultan Healthcare 1301 Smile Way • York, PA 17404 • USA Toll Free: 800-637-8582 • Phone: 201-871-1232 Fax: 201-871-0321 • www.sultanhealthcare.com Made in the USA 0031001DF, R4-072017"],"storage_and_handling":["8. HOW SUPPLIED / STORAGE AND HANDLING Topex 20% benzocaine gel is supplied in multiple use containers. Store between 59°-86°F (15°-30°C). Protect from freezing."],"version":"12","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 jar by reintroducing a used cotton applicator into the jar"]}