FDA Label for Lidocaine 4%

Active Ingredients

Lidocaine 4% w/w

Other Ingredients

Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Purpose & Use

External Anesthetic - For temporary relief of pain

Warnings

For external use only.

Dosage & Administration

Adults and Children 12 Years of Age or Over:

• Apply one 4% lidocaine patch at a time to the affected area.
• Use up to 3 times daily, with each application lasting no more than 8 hours.
• Clean and dry the skin before applying the patch.
• Remove the patch after the specified duration and reseal the pouch containing unused patches.

Children Under 12 Years of Age: Consult a doctor for use.

Precautions:

• Avoid applying to broken or irritated skin.
• Do not apply more than one patch at a time.
• Avoid using local heat sources on the area where the patch is applied.

Do Not Use

Do not use:

• on the face or rashes, on wounds or damaged skin
• in the eyes, mouth, or other mucous membranes
• on genitals
• with a heating pad
• right before or after heart surgery
• any patch from a pouch that has been opened for 7 or more days
• in large quantities, particularly over raw surfaces or blistered areas
• if tamper-evident seal is torn, broken, or missing
• more than 2 patches per day unless directed by a doctor
• children under 18 years of age

Ask a doctor before use if you have:

• allergies to topical products
• high blood pressure, heart disease, or kidney disease

When using this product, avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

The risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant of breast-feeding, ask a health professional before use

Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

If put in mouth, seek medical help or contact a Poison Control Center right away.

Dispose if the used patches by folding sticky ends together.

Uses:

For temporary relief of pain

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When Using This Product

• Use only as directed
• Avoid contact with the eyes, mucous membranes or rashes
• Do not bandage

Stop Use ... If

• Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• Conditions worsen
• Symptoms persists for more than 7 days
• Symptoms clear up and occur again within a few days

Consult With A Doctor Or Pharmacist Before Continued Use If

• Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• Conditions worsen
• Symptoms persists for more than 7 days
• Symptoms clear up and occur again within a few days

If You Are Pregnant Or Breast-Feeding

ALWAYS FIRST CONSULT WITH A HEALTH PROFESSIONAL

Keep Out Of The Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Other Information

• Some individuals may not experience pain relief until several minutes or hours after applying the patch
• Avoid storing product in direct sunlight
• Protect product from excessive moisture

Questions?

Call toll-free: (307) 410-3813 or Email: [email protected]

85096-201-01

85096-201-01: 1 patch in 1 pouch: