Zylorelief
Rapid-onset topical analgesic
Zylorelief Cream
FDA Label NDC 87450-208
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Highmark Pharma Llc for the product Zylorelief (NDC 87450-208). 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 zylorelief, active ingredients, purpose, uses, warnings, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Lidocaine HCL 4.0%
Purpose
External analgesic
Uses
For temporary relief of pain and itching due to minor skin irritations.
Warnings
- For external use only.
- Avoid contact with eyes.
Directions
For adults and children two-years or older: Apply 1 packet (2 grams) topically to the affected area(s) up to 4 times daily as needed for pain. Do not use more than 4 packets (8 grams) per day.
Inactive Ingredients
Arnica Montana Extract, C13-14 Isoalkane, Dimethyl Sulfone, Emu Oil (Dromiceius), Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Isopropyl Palmitate, Laureth-7, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine, Water (Aqua)
Other Information
Protect this product from excessive heat and direct sun.
Product Label
Pdp
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