Lidozen
FDA Label NDC 71574-900

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Village Pharma, Llc for the product Lidozen (NDC 71574-900). 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:, uses:, warnings:, do not use, if pregnant or breast-feeding,, keep out of reach of children., directions (adults and children over 12 years):, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Lidocaine 4.00%

Menthol 1.00%

Uses:

For temporary relief of pain

Warnings:

  • For external use only.
  • Avoid contact with eyes.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Do Not Use

  • in large quantities, particularly over raw surfaces or blistered areas.

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 (Adults And Children Over 12 Years):

Clean and dry affected area.

Remove patch from backing and apply to affected area.

Use only one patch at a time, and maximum of four patches / day.

Leave patch on affected area for up to 8 hours

Do not use patches for longer than five consecutive days,

Children under 12 should consult physician prior to use.

Inactive Ingredients:

Water, Glycerol, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben

* Please review the disclaimer below.