Active Ingredients
Lidocaine 4% w/w
The following Structured Product Label (SPL) was submitted to the FDA by Marcella Health for the product Lidocaine 4% (NDC 85096-201). 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, other ingredients, purpose & use, warnings, dosage & administration, do not use, uses:, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Lidocaine 4% w/w
Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.
External Anesthetic - For temporary relief of pain
For external use only.
Adults and Children 12 Years of Age or Over:
Children Under 12 Years of Age: Consult a doctor for use.
Precautions:
Do not use:
Ask a doctor before use if you have:
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.
For temporary relief of pain
ALWAYS FIRST CONSULT WITH A HEALTH PROFESSIONAL
If swallowed, get medical help or contact a Poison Control Center right away.
Call toll-free: (307) 410-3813 or Email: [email protected]
85096-201-01: 1 patch in 1 pouch:
* Please review the disclaimer below.