Active Ingredients
Lidocaine 4% w/w
Menthol 1% w/w
Zylotrol Maximum Pain Patch
FDA Label NDC 81902-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Whitestone Products Llc for the product Zylotrol Maximum Pain (NDC 81902-104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, do not use:, when using this product:, stop use and ask a doctor if:, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Principal Display Panel
Label (Label)
* Please review the disclaimer below.
