Lidocaine Hcl Cream
FDA Label NDC 87137-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Matthias Therapeutics, Llc for the product Lidocaine Hcl (NDC 87137-101). 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 ingredient, purpose, 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

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding

→ Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Storage And Handling

→ Questions?

→ How Supplied

→ Principal Display Panel

Active Ingredient

Lidocaine HCl 4%

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain

Warnings

For external use only

Do Not Use

on puncture wounds
on large area of the body or on cut, irritated, or swollen
skin for more than one week without consulting a doctor

When Using This Product

use only as directed. Read and follow all directions and warnings on this carton.
do not use in large quantities, particularly over raw surfaces or blistered areas
do not allow contact with eyes
do not bandage or apply local heat (such as heating pad) to the area of use
do not use at the same time as other topical analgesics
For CA Residents Only: TEA does not conform to Proposition 65

Stop Use And Ask A Doctor If

condition worsens, redness is present, or irritation develops symptoms persist for more than 7 days or 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

adults and children 12 years and older: Apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period.
children under 12 years: Ask a doctor