Lidocaine Cream
FDA Label NDC 71457-525

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Invaderm Corporation for the product Lidocaine Cream (NDC 71457-525). 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, otc - keep out of reach of children, directions, other information, inactive ingredient, 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

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredient

→ Principal Primary Panel - Carton

Active Ingredient

Lidocaine 5% W/W

Purpose

Local Anesthetic

Uses

Temporarily relieves pain and itchingdue to anorectal disorders.

Warnings

When using this product

avoid contact with eyes
do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor if

rectal bleeding occurs
condition worsens or does not improve within 7 days
allergic reaction occurs
redness, irritation, swelling, pain or other symptoms begin or increase
symptoms clear up and return within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

When practical, clean affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
Children under 12 years of age: Ask a doctor.