FDA Label for Zylotrol Maximum Pain

Active Ingredients

Lidocaine 4% w/w

Menthol 1% w/w

Purposes

Topical analgesic

Topical analgesic

Uses

For the temporary relief of pain.

Warnings

For external use only

Do Not Use:

• More than 1 patch at a time
• On wounds or damaged skin
• For more than one week without consulting a doctor
• If you are allergic to any ingredients of this product

When Using This Product:

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

Stop Use And Ask A Doctor If:

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

If Pregnant Or Breast-Feeding,

Ask a health professional before use

Keep Out Of Reach Of Children.

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

Directions

Adult and children 12 years of age and over:

• Clean and dry affected area
• Remove film from patch and apply to the skin (see illustration)
• Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
• Remove patch from the skin after at most 8-hour application

Children under 12 years of age: Consult a doctor

Other Information

• Store at 68-77℉ (20-25℃)
• Store in a cool dry place away from direct sunlight

Inactive Ingredients

Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Polysorbate 80, Mineral oil, Polyvinylpyrrolidone K90, Hydroxyacetophenone, L(+)-Tartaric Acid, Dihydroxyaluminium Aminoacetate, Edetate Disodium, Kaolin, Titanium Dioxide

Questions?

(310) 320-0100

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