Is RectoProtect a prescription drug?

No. RectoProtect is sold over the counter (OTC) without a prescription.

Are there other products with the same active ingredient as RectoProtect?

Yes. Other FDA-listed products with the same active ingredients include Pain Relief Patches, Burn Relief, LIDOCAINE PAIN RELIEF Gel-Patch, Lidocaine Numbing Cream.

Who makes RectoProtect?

Akron Pharma Inc. lists RectoProtect with the FDA.

Checked Oct 30, 2026

OTC

RectoProtect

lidocaine · RectoProtect is an amide local anesthetic (over-the-counter) containing lidocaine, made by Akron Pharma Inc..

Type: Over the counter
Drug class: Amide Local Anesthetic
Route: Topical
Manufacturers: 1

Temporarily relieves pain and itching due to anorectal disorders

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Class IIDrugOngoing10/14/2026Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro...Preferred Pharmaceuticals, Inc. · Failed Content Uniformity Specifications
Class IIDrugOngoing09/23/2026Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc....SUN PHARMA /TARO · Failed Content Uniformity Specifications. Out of Specification for...
Class IIDrugOngoing07/29/2026Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx...Fresenius Kabi USA, LLC · 3 products · Presence of Particulate Matter: Hair was found in products
Class IIIDrugOngoing07/29/2026Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only...Asclemed USA Inc. · Labeling: Not Elsewhere Classified: The label wrap covers the...
Class IIDrugOngoing07/08/2026Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only...Asclemed USA Inc. · 2 products · Lack of Assurance of Sterility

Active ingredients

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

Temporarily relieves pain and itching due to anorectal disorders

Directions

When practical, clean 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

Warnings

When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor

When using this product

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

Stop use and ask a doctor

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredients

Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cholesterol, Isopropyl myristate, Mineral Oil, Polysorbate 80, Propylene Glycol, Purified Water, Tocopherol, Trolamine

Questions?

Call toll-free 1-877-255-6999 Manufactured for: Akron Pharma Inc. Fairfield, Nj 07004 www.akronpharma.com

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage form	Strength	Route	NDCs
Cream	5 g/100g	topical	1

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 57,974 reports that list lidocaine, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

Drug ineffective4,341
Off label use4,128
Pain3,661
Fatigue3,499
Product adhesion issue3,452
Nausea3,399
Headache3,311
Product quality issue3,206
Sinusitis2,562
Dyspnea2,403

To report a side effect, use FDA MedWatch.

Manufacturers and labels

1 FDA label

Akron Pharma Inc.Shown hereM017 · Label 07/27/2026 · NDC 71399-0050Full label

RectoProtect: common questions

What is RectoProtect used for?: Temporarily relieves pain and itching due to anorectal disorders
Is RectoProtect a prescription drug?: No. RectoProtect is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as RectoProtect?: Yes. Other FDA-listed products with the same active ingredients include Pain Relief Patches, Burn Relief, LIDOCAINE PAIN RELIEF Gel-Patch, Lidocaine Numbing Cream.
Who makes RectoProtect?: Akron Pharma Inc. lists RectoProtect with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/27/2026 · Label text is shown as published by the manufacturer. Not medical advice

Generic name: lidocaine
Active ingredients: Lidocaine
Drug class: Amide Local Anesthetic Antiarrhythmic
Dosage forms: Cream
Label holder: Akron Pharma Inc.
FDA application: M017
Label updated: 07/27/2026

Same active ingredients

Generics and other brands

Same drug class

Amide Local Anesthetic

All

Data sources

openFDA drug labels (SPL)U.S. Food and Drug Administration
NDC DirectoryDosage forms, strengths and packages
DailyMedFull labels from the National Library of Medicine

Data as of 07/27/2026

Do not rely on openFDA to make decisions regarding medical care. While FDA makes every effort to ensure that data is accurate, all results should be assumed unvalidated. This page is for information only and is not medical advice. Talk to your doctor or pharmacist before starting, stopping or changing any medicine.

Related health info

About this data

Health and medical: This page is for general information only and is not medical advice. It does not replace a doctor, pharmacist or other licensed professional. Do not start, stop or change any treatment based on this page. If you think you have a medical emergency, call 911. If you are in crisis, call or text 988.

DatenUS is a private website and is not affiliated with or endorsed by any government agency. We republish public data from the sources listed on this page. Data can be incomplete, delayed or wrong. Always check the original source before you make a decision.

Our servers read this data automatically from government sources. Errors can come from the source itself or from the way we read, process or display it, and we do not guarantee that it is accurate, complete or current. Verify anything important with the official source.

Report an error Read the full disclaimer