Lidocaine

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION

Local anesthetic

Uses

INDICATIONS & USAGE SECTION

Helps relieve pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

• avoid contact with eyes
• do not exceed recommended dosage unless directed by a doctor
• do not put this product into the rectum by using fingers or any mechanical device or applicator

OTC - STOP USE SECTION

Stop use and ask a doctor if

• rectal bleeding occurs
• condition worsens or does not improve within 7 days
• allergic reaction occurs
• symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
• symptoms clear up and return within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• When practical, cleanse the 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: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

• Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer, lecithin, propylene glycol, purified water, vitamin E acetate.

SPL UNCLASSIFIED SECTION

Distributed by:
Alvogen, Inc.
Pine Brook, NJ 07058 USA

Toll Free: 1-866-770-3024

Rev. 01/2019

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47781-571-73

Lidocaine 5%
Anorectal Cream

NET WT. 30 grams

Related RxNorm Concepts#

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

• Lidocaine
• Water
• Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)
• Propylene Glycol
• Benzyl Alcohol
• .Alpha.-Tocopherol Acetate
• Egg Phospholipids

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.