Lidocaine Anorectal Cream
FDA Label NDC 85833-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Everymarket Inc for the product Lidocaine Anorectal Cream (NDC 85833-001). 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 active ingredient                             purpose, directions, warnings (for external use only), keep out of reach of children, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                             Purpose

Lidocaine 5%                                    Local Anorectal(hemorrhoidal) Anesthetic

Directions


Adults: 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 a soft cloth before application of this product.
• Apply to the affected area up to 6 times daily.
Children under 12 years of age: consult a doctor

Warnings (For External Use Only)


• If condition worsens or does not improve within 7 days, consult a doctor.

• Do not exceed the recommended daily dosage unless directed by a doctor.
• In case of bleeding, consult a doctor promptly.
• Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop and ask a doctor if -an allergic reaction occurs - symptom does not improve or if redness, irritation, swelling, pain or other symptom develop or increase.

Keep Out Of Reach Of Children

. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.
(1-800-222-1222)

Inactive Ingredients

Benzyl Alcohol, Carbomer, Cholesterol, DL ALPHA Tocopheryl Acetate.Hydrogenated Lecithin, lsopropyl Myristate, Polysorbate80, Propylene Glycol, Triethanolamine, Water

* Please review the disclaimer below.