{"active_ingredient":["Active ingredient Lidocaine 4% w/w"],"do_not_use":["OTC - DO NOT USE do not use in or near the eyes do not use in large quantities, particularly over raw surfaces or blistered areas"],"dosage_and_administration":["Directions Shake vigorously before each use. Prime container before initial use: Shake vigorously and then hold ANESTAFOAM can upright, direct away from patient and depress the actuator until foam begins to dispense. Adults and children 2 years and older: Apply to palm of hand, then externally to the affected area up to 3 to 4 times a day. Children under 2 years of age: Consult a physician. See package insert for additional information."],"effective_time":"20110610","id":"fb5356f2-5433-41d9-8563-15337870d328","inactive_ingredient":["Inactive ingredients benzalkonium chloride NF, benzyl alcohol NF, isopropyl myristate NF, polysorbate 80 NF, propellant HFA-134a (1,1,1,2-tetrafluoroethane), propylene glycol USP, purified water USP"],"indications_and_usage":["Uses: Temporarily relieves pain and itching due to: minor cuts minor burns minor scrapes sunburn minor skin irritations insect bites"],"keep_out_of_reach_of_children":["OTC - KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Anestafoam Outer Carton Child Resistant - 30g NDC 16781-126-30 Anestafoam ® (Lidocaine 4%) Topical Anesthetic Foam Pain Relief Foam Net Weight 30g","PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Anestafoam Inner Label Child Resistant - 30g Anestafoam ® (Lidocaine 4%) Topical Anesthetic Foam NDC 16781-126-30 Net Weight 30g Anestafoam Outer Carton Child Resistant - 30g Anestafoam Inner Label Child Resistant - 30g"],"purpose":["Purpose Topical anesthetic"],"set_id":"a2c34f8c-3b33-47ca-86f5-6a4ea588faa6","spl_patient_package_insert":["Anestafoam PI What is ANESTAFOAM ® ? ANESTAFOAM is a brand name for a topical anesthetic foam containing a non-prescription strength lidocaine. What is lidocaine used for? Lidocaine can relieve the pain caused by minor cuts, minor burns, abrasions, sunburn, and insect bites. How does ANESTAFOAM work? Lidocaine causes a temporary loss of feeling in the skin and surrounding tissue. ANESTAFOAM may induce a slight cooling sensation followed by increased numbing at the site of application. What is in ANESTAFOAM? ANESTAFOAM contains a 4% concentration of lidocaine. It also contains benzalkonium chloride NF, benzyl alcohol NF, isopropyl myristate NF, polysorbate 80 NF, propellant HFA- 134a (1,1,1,2-tetrafluoroethane), propylene glycol USP and purified water USP. If you think you or your child might be sensitive to any of the ingredients in ANESTAFOAM, check with your doctor or pharmacist before using this product. What are the directions for use? Shake Vigorously and Prime Before Initial Use. Shake Vigorously Before Each Use. To Prime: shake vigorously, then hold the ANESTAFOAM can upright, direct away from the patient, and depress the actuator for 1 to 3 seconds or until foam begins to dispense. Apply ANESTAFOAM to palm of hand and then apply to affected areas no more than 3 to 4 times daily. TO OPEN CHILD RESISTANT CAP: 1. Hold collar with one hand. 2. Turn cap using the other hand until the arrows on the side of the collar and cap are aligned (><). 3. Pull the cap off the container. TO CLOSE AND LOCK CHILD RESISTANT CAP: 1. Align the arrows (><) on the side of the collar and cap and snap the cap onto the container. 2. Hold collar with one hand and turn cap using the other hand until the arrows on the side of the collar and cap are no longer aligned. How do I use ANESTAFOAM with children? Do not apply ANESTAFOAM to children under two years of age without consulting a physician. Although it is not necessary to cover the area with a secondary dressing after application of ANESTAFOAM, it is recommended when using this product on young children to prevent accidental ingestion. What precautions should I take when using ANESTAFOAM? ANESTAFOAM causes a temporary loss of feeling at the site of application; carefully avoid injury to the treated area while it is numb. ANESTAFOAM should never be used internally. Do not put ANESTAFOAM in your mouth, ears, eyes or nose. If swallowed, seek immediate medical help or contact a Poison Control Center right away. In the event of foam contacting your eyes, immediately wash out the eye with water, protect the eye until sensation returns, and consult your physician. Application of ANESTAFOAM to larger areas, or more frequently than recommended, could result in excessive absorption of lidocaine and result in serious adverse effects. Are there any side effects associated with using ANESTAFOAM? Although uncommon, side effects may occur and, if persistent, should be reported to your health care provider. The most common side effects are irritation, redness, itching, and rash. If you notice any unusual effects such as blurred vision, dizziness or drowsiness, difficulty breathing, trembling, chest pain, or irregular heartbeat, immediately contact a health care professional. How do I store ANESTAFOAM? Keep out of the reach of children. Keep container closed properly when not in use. Contents under pressure. Do not puncture or incinerate container. Store at room temperature 59º - 86º F (15º - 30º C). Do not expose to temperatures above 120º F (49º C). Dispose any unused medicine after the expiration date. How is ANESTAFOAM supplied? 30g Aerosol Can (Child-Resistant Packaging) NDC: 16781-126-30 30g Aerosol Can (Non Child-Resistant Packaging) NDC: 16781-126-32 Onset Therapeutics Cumberland RI 02864 888-713-8154 www.onsettx.com Patent Pending P/N: 2608 Rev. 1 Anestafoam Logo Onset Logo"],"spl_product_data_elements":["Anestafoam LIDOCAINE LIDOCAINE LIDOCAINE PROPYLENE GLYCOL WATER POLYSORBATE 80 ISOPROPYL MYRISTATE BENZALKONIUM CHLORIDE BENZYL ALCOHOL"],"spl_unclassified_section":["Drug Facts","Other Information May be applied under occlusive dressing. Store at controlled room temperature 59º - 86ºF (15º - 30ºC). Do not expose to temperatures above 120ºF (49ºC). Contents under pressure. Do not puncture or incinerate container."],"stop_use":["OTC - STOP USE Stop use and ask a doctor if: allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase"],"version":"6","warnings":["Warnings OTC - WHEN USING For External Use Only OTC - DO NOT USE do not use in or near the eyes do not use in large quantities, particularly over raw surfaces or blistered areas OTC - STOP USE Stop use and ask a doctor if: allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase"],"when_using":["OTC - WHEN USING For External Use Only"]}