Aloe Vera Burn Relief Spray with Lidocaine

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before you use other drugs or products on your skin.
• Do not use Aloe Vera Burn Relief Spray with Lidocaine for longer than you were told by your doctor.
• Do not scratch or rub the skin while it is numb. Do not let it get very hot or very cold.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
• Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
• Do not put on cuts, scrapes, or damaged skin unless the doctor tells you to.
• Avoid use of heat sources (such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, heated waterbeds). Avoid long, hot baths or sunbathing. Your temperature may rise and cause too much drug to pass into your body.
• This medicine may cause harm if swallowed. If this medicine is swallowed, call a doctor or poison control center right away.
• If you are 65 or older, use Aloe Vera Burn Relief Spray with Lidocaine with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature. Do not freeze.
• Protect from heat.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Protect from heat or open flame. Do not puncture or burn even if it seems empty.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Aloe Vera Burn Relief Spray with Lidocaine (lidocaine aerosol), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aloe Vera Burn Relief Spray with Lidocaine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Aloe Vera Burn Relief Spray with Lidocaine.

Review Date: October 4, 2017

Applies to lidocaine topical: topical application aerosol liquid, topical application cream, topical application dressing, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment, topical application pad, topical application patch extended release, topical application powder, topical application solution, topical application spray

Along with its needed effects, lidocaine topical (the active ingredient contained in Aloe Vera Burn Relief Spray with Lidocaine) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lidocaine topical:

• Blistering, crusting, irritation, itching, or reddening of the skin
• cough
• cracked, dry, or scaly skin
• fast heartbeat
• fever
• hives or welts, itching, or skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

• Blistering, bruising, burning, discoloration, itching, redness, or swelling at the application site
• blurred vision
• chest pain or discomfort
• cold, clammy, or pale skin
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness or dizziness
• false or unusual sense of well-being
• fear or nervousness
• irregular, fast or slow, or shallow breathing
• lethargy
• no blood pressure or pulse
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness in the legs, arms, hands, or feet
• slow heart rate
• slow or irregular heartbeat
• stopping of heart
• trembling or shaking of the hands or feet
• twitching
• unconsciousness
• unusual tiredness or weakness
• weakness

Some side effects of lidocaine topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bad, unusual, or unpleasant (after) taste
• change in taste
• cold or numbness
• confusion about identity, place, and time
• continuing ringing or buzzing or other unexplained noise in the ears
• double vision
• headache
• hearing loss
• heat sensation
• lack or loss of strength
• metallic taste
• sleepiness or unusual drowsiness

2% viscous solution: Gargle 15 mL, undiluted, and spit out or swallow, no less than every 3 hours
Maximum dose: 300 mg for normal healthy adult - not to exceed 4.5 mg/kg (2 mg/lb), or 8 doses in 24 hours

Comments:
-Adjust dose based on patient's age, weight, and physical condition.

Uses:
-Topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx
-Reducing gagging during dental x-rays and impressions

----
2% jelly:
Endotracheal intubation: Apply a moderate amount of jelly to the external surface of the endotracheal tube shortly before insertion
Maximum dose: 600 mg in any 12 hour period
Comments:
-Avoid introducing jelly into tube lumen due to possibility of inner lumen occlusion.
-Do not use the jelly to lubricate endotracheal stylettes.
-Avoid use of endotracheal tubes with dried jelly on the external surface due to lack of lubricating effect.

4% solution: Spray 1 to 5 mL (40 to 200 mg) to the desired area. May also be applied with cotton applicators or by instillation
Maximum dose: 300 mg for normal healthy adult - not to exceed 4.5 mg/kg (2 mg/lb)
Comments:
-When spraying, transfer solution to an atomizer.
-Dosage varies and depends on the area to be anesthetized, vascularity of the tissues, individual tolerance, and technique.
-Reduce dose for elderly and debilitated patients.

5% ointment: Apply topically for adequate control of symptoms. Apply to the tube prior to intubation
Maximum dose: 5 g per single application (approximately 6 inches of ointment squeezed from the tube); 20 g total in any day
Comments:
-Adjust dose based on patient's age, weight, and physical condition.
-In dentistry, apply to previously dried oral mucosa; subsequent saliva removal with cotton rolls or saliva ejector minimizes dilution, permits maximum penetration, and minimizes swallowing of the drug.
-For insertion of new dentures, apply to all denture surfaces contacting mucosa; patients should consult a dentist at least every 48 hours throughout the fitting period.

Uses:
-Production of anesthesia of accessible mucous membranes of the oropharynx
-Anesthetic lubricant for endotracheal intubation (oral and nasal)

2% Oral solution (viscous):
Infants and children less than 3 years: One quarter teaspoon applied to area with a cotton tipped applicator no more frequently than every 3 hours
Maximum dose: 4 doses per 12 hour period
Children 3 years and older: No more than 4.5 mg/kg/dose (or 300 mg/dose), swished in the mouth and spit out no more frequently than every 3 hours
Comments:
-Do not use for teething pain.
-Adjust dose based on patients age, weight, and physical condition.
-Children under ten years with normal lean body mass and development; determine the maximum dose by the applying of one of the standard pediatric drug formulas (e.g., Clark's rule).

Uses:
-Topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx.
-Reducing gagging during dental x-rays and impressions

----
Pediatric LTA(R) 2% spray:
For laryngoscopy, bronchoscopy, and endotracheal intubation: Spray pharynx with 1 to 5 mL
Maximum dose: 4.5 mg/kg (2 mg/lb)
Comments:
-Dosage in children should be reduced, commensurate with age, body weight and physical condition.
-Children under ten years with normal lean body mass and development; determine the maximum dose by the applying of one of the standard pediatric drug formulas (e.g., Clark's rule).

2% jelly:
Endotracheal intubation: Apply a moderate amount of jelly to the external surface of the endotracheal tube shortly before insertion
Maximum dose: 4.5 mg/kg (2 mg/lb)
Comments:
-Avoid introducing jelly into tube lumen due to possibility of inner lumen occlusion.
-Do not use the jelly to lubricate endotracheal stylettes.
-Avoid use of endotracheal tubes with dried jelly on the external surface due to lack of lubricating effect.

2%, 4%, or 5% solution: Spray on the desired area. May also be applied with cotton applicators or by instillation
Maximum Dose: 4.5 mg/kg (2 mg/lb)
Comments:
-When spraying, transfer solution to an atomizer.
-Dosage varies and depends on the area to be anesthetized, vascularity of the tissues, individual tolerance, and technique.
-Reduce dose in children commensurate with age, body weight and physical condition.
-Children under ten years with normal lean body mass and development: determine the maximum dose by the applying of one of the standard pediatric drug formulas (e.g., Clark's rule).

5% ointment: Apply topically for adequate control of symptoms. Apply to the tube prior to intubation
Comments:
-Adjust dose based on patient's age, weight, and physical condition.
-In dentistry, apply to previously dried oral mucosa; subsequent saliva removal with cotton rolls or saliva ejector minimizes dilution, permits maximum penetration, and minimizes swallowing of the drug.
-For insertion of new dentures, apply to all denture surfaces contacting mucosa; patients should consult a dentist at least every 48 hours throughout the fitting period.

Uses:
-Production of anesthesia of accessible mucous membranes of the oropharynx.
-Anesthetic lubricant for endotracheal intubation (oral and nasal).

US BOXED WARNING:
-Do Not Use Lidocaine to Treat Teething Pain in Children.
-Prescription oral viscous lidocaine 2% solution is not approved for, and should not be used for, treating infants & children with teething pain.
-Its use for this purpose has resulted in serious harm and deaths.
-Rubbing topical pain relievers on gums is not useful or effective because they wash out of the baby's mouth within minutes, and when too much is swallowed, it can result in seizures, severe brain injury, and cardiac toxicity.
-The American Academy of Pediatrics recommends the use of chilled teething rings or rubbing the child's gums with a finger to relieve the symptoms of teething pain, instead of the use of topical medications.

5% Patch: Safety and efficacy have not been established in patients younger than 18 years.

0.5% Intradermal injection system: Safety and efficacy have not been established in patients younger than 3 years.

Consult WARNINGS section for additional precautions.

Use is not recommended unless clearly needed. AU TGA pregnancy category: A US FDA pregnancy category: B Comment: Medical supervision is recommended during pregnancy.

This drug crosses the placenta. Animal studies did not show evidence of harm to the fetus. There are no adequate or well-controlled studies in pregnant women. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.