Lidocoll
FDA Label NDC 51715-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Innocoll Pharmaceuticals for the product Lidocoll (NDC 51715-001). 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 otc - active ingredient, purpose, warning, use, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Lidocaine HCl 4%...............Anesthetic

Purpose

Anasthetic

Warning

Keep out of reach of children

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 and consult a doctor.
Keep out of reach of children.

Use

For the temporary relief of pain anditching associated with minor burns,sunburn, minor cuts, scrapes, insectbites or minor skin irritations.

Directions

Adults and children 2 years of age
and older: Apply Lidocoll spray not
more than 3 to 4 times per day or
moisten dressing prior to removal
to reduce pain.
Children under 2 years of age
consult a doctor.

Inactive Ingredients

hydrolyzed fish collagen (15%),
purified water, benzethonium
chloride and HCl.

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