ANORECTAL Lidocaine Cream

Manufacturer
RUGBY LABORATORIES | Strive Pharmaceuticals Inc.
Effective date
2021-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:36:57

Label at a glance#

ProductANORECTAL Lidocaine Cream
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

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

Dosage and administration

• 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.

Storage and handling

Store at room temperature (20-25°C) (68-77°F). Avoid excessive heat and cold. Protect from sunlight.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION

Local anesthetic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

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

Stop use and ask a doctor if
• rectal bleeding occurs
• condition worsens or does not improve within 7 days
• allergic reaction occurs to ingredients in this product
• 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

If pregnant or breast feeding, ask a health professional before use.

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, 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.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature (20-25°C) (68-77°F). Avoid excessive heat and cold. Protect from sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, triethanolamine, vitamin E

Questions?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Recticare® Anorectal Cream††

• For the temporary relief of anorectal itching & discomfort associated with hemorrhoids

• Helps relieve pain, soreness & burning

• Highest OTC lidocaine strength available

+ 10 FINGER COTS*

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF THE TUBE IS DAMAGED OR TAMPERED WITH.

Close cap tightly after each use.

††This product is not manufactured or distributed by Ferndale Healthcare®, Inc., a subsidiary of Ferndale Pharma Group, Inc., owner of the registered trademark RectiCare®.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby-1339Rugby-1339

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-1339-282025-02-13C16284748780-12cef2736-7aab-d83d-e063-dadaa90ab31fANORECTAL Lidocaine Cream
0536-1339-282025-01-30C16284748780-12cef2736-7aab-d83d-e063-dadaa90ab31fANORECTAL Lidocaine Cream

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-13390536-1339-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a78a61f3-5591-435e-b6b0-16230a4b2520bfeafe34-f502-4cbe-9197-4980100848da2025-02-13WarningsExact identifier
spl set id: bfeafe34-f502-4cbe-9197-4980100848da

Reported adverse events (FAERS/openFDA)#

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