Solarcaine Aloe Extra

• It is used to stop pain.
• It is used to ease pain from skin irritations.
• It may be given to you for other reasons. Talk with the doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat the does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
• Trouble breathing, slow breathing, or shallow breathing.
• Very bad numbness and tingling.
• Feeling lightheaded, sleepy, having blurred eyesight, or a change in thinking clearly.
• Seizures.
• Change in eyesight.
• Feeling nervous and excitable.
• Dizziness or passing out.
• Ringing in ears.
• Upset stomach or throwing up.
• Feeling hot or cold.
• Shakiness.
• Twitching.
• Slow heartbeat.
• Very bad irritation where this medicine is used.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Redness.
• Swelling.
• Change in color of skin.
• Irritation where Solarcaine Aloe Extra (lidocaine gel) is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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 Solarcaine Burn Relief) 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

Applies to lidocaine topical: intradermal device, mucous membrane solution, mucous membrane spray, topical cream, topical film, topical gel, topical gel with applicator, topical kit, topical liquid, topical lotion, topical ointment, topical solution, topical spray, topical stick

General

The most common adverse events were administration site reactions: burning, dermatitis, erythema, pruritus, rash, skin irritation, and vesicles.[Ref]

Dermatologic

Very common (10% or more): Erythema (up to 67.3%), petechiae (up to 46.4%)
Common (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Skin lesion, skin injury
Frequency not reported: Flushing, cutaneous lesions, urticaria, dermatitis[Ref]

Local

Very common (10% or more): Administration site reactions
Common (1% to 10%): Irritation, redness, itching, application site erythema, application site burning, application site pain, application site pruritus, edema
Uncommon (0.1% to 1%): Venipuncture site hemorrhage, burning sensation
Frequency not reported: Locus of abnormal sensation, paleness (pallor or blanching), alteration in temperature sensation, blisters, bruising, depigmentation, dermatitis, discoloration, exfoliation, papules, petechiae, vesicles, application site dermatitis, application site vesicles, skin irritation[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness
Frequency not reported: Lightheadedness, nervousness, apprehension, euphoria, confusion, drowsiness, tinnitus, nystagmus, headache, nausea, vomiting, sensations of heat, cold or numbness, twitching, tremors, paraesthesia, convulsions, unconsciousness, respiratory depression and arrest, pain and/or dysesthesia in the buttocks or legs, unconsciousness
Postmarketing reports: Headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, somnolence, taste alteration[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting[Ref]

Immunologic

Common (1% to 10%): Nasopharyngitis[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic reaction, hypersensitivity
Frequency not reported: Anaphylactoid reactions, anaphylactic shock, angioedema, bronchospasm, shock, dyspnea, laryngospasm[Ref]

Cardiovascular

Frequency not reported: Bradycardia, hypotension, arrhythmia, cardiovascular collapse, cardiac arrest, AV block, myocardial depression[Ref]

Hematologic

Frequency not reported: Methemoglobinemia[Ref]

Ocular

Frequency not reported: Corneal irritation, blurred or double vision
Postmarketing reports: Visual disturbances[Ref]

Respiratory

Rare (less than 0.1%): Endotracheal tube occlusion
Frequency not reported: Sore throat, hoarseness, loss of voice[Ref]

Psychiatric

Frequency not reported: Confusion, psychosis, disorientation, dizziness[Ref]

Other

Postmarketing reports: Open wound, asthenia, pain exacerbated[Ref]

Some side effects of Solarcaine Burn Relief may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.