FDA.reportPublic FDA data

LANOZEM HEMORRHOIDAL OINTMENT

Manufacturer
Sod-e Biotech Ltd
Effective date
2025-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:37

Label at a glance#

ProductLANOZEM HEMORRHOIDAL
Active ingredientMENTHOL, PETROLATUM
Label structure8 sections

Indications and uses

Helps relieve the itching and discomfort associated with hemorrhoids, inflamed hemorrhoidal tissues, anorectal disorders and anorectal inflammation Temporarily protects irritated areas Temporarily provides a coating for relief of anorectal discomforts Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful Temporarily relieves the symptoms of perianal skin irritatio...

Dosage and administration

adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by blotting or patting with a tissue or a soft cloth before applying ointment. Apply to the affected area up to 6 times daily, especially at night, in the morning or after ' each bowel movement. EXTERNAL USE: Apply to external anal area. INTRARECTAL USE: Lubricate applicator well with Lonazem oin...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.1%
Petrolatum 80%

Purpose

OTC - PURPOSE SECTION

Menthol…….Antipruritic
Petrolatum…..Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps relieve the itching and discomfort associated with hemorrhoids, inflamed hemorrhoidal tissues, anorectal disorders and anorectal inflammation
  • Temporarily protects irritated areas
  • Temporarily provides a coating for relief of anorectal discomforts
  • Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • Temporarily relieves the symptoms of perianal skin irritation
  • Temporarily protects inflamed perianal skin
  • For the temporary relief of pain or burning
  • May provide a cooling sensation

Warnings

WARNINGS SECTION

For external and/or intrarectal use only

Do not insert the applicator into the rectum if it causes additional pain. Consult a doctor promptly.

If Pregnant or Breastfeeding, ask a healthcare provider before using.

When using this product

OTC - WHEN USING SECTION

  • 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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by blotting or patting with a tissue or a soft cloth before applying ointment.
  • Apply to the affected area up to 6 times daily, especially at night, in the morning or after ' each bowel movement.
  • EXTERNAL USE: Apply to external anal area.
  • INTRARECTAL USE: Lubricate applicator well with Lonazem ointment, then gently insert applicator into the rectum.
  • Children under 12 years of age: consult a doctor

Other Information

OTHER SAFETY INFORMATION

You may report a serious side effects to: Dorrington LLC, 7 Skyline Dr., Suite 350, Hawthorne, NY 10532

Inactive ingredients

INACTIVE INGREDIENT SECTION

butyrospermum parkii (shea) butter, cetearyl alcohol, juniper berry volatile oil, origanum vulgare leaf extract, rosmarinus officinalis leaf extract, thymus vulgaris leaf extract, zea mays (corn) oil

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2675775menthol 0.1 % / petrolatum 80 % Rectal OintmentPSN1
2675775menthol 0.001 MG/MG / petrolatum 0.8 MG/MG Rectal OintmentSCD1
2675775menthol 0.1 % / petrolatum 80 % Rectal OintmentSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84483-0010-1LANOZEM HEMORRHOIDAL3 g in 1 TUBEOINTMENT31
84483-0010-1LANOZEM HEMORRHOIDAL10 in 1 CARTONOINTMENT101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84483-0010LANOZEM HEMORRHOIDAL (MENTHOL, PETROLATUM) OINTMENT [SOD-E BIOTECH LTD]1Current NDC, 2 package rows20250509_34901e83-8f24-8460-e063-6394a90a2744.zip

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
84483-001084483-0010-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
JUNIPER BERRY OILSZH16H44UYIACT
OREGANO0E5AT8T16UIACT
THYMUS VULGARIS LEAFGRX3499643IACT
ROSEMARYIJ67X351P9IACT
CORN OIL8470G57WFMIACT
SHEA BUTTERK49155WL9YIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MENTHOLL7T10EIP3AACTIB
PETROLATUM4T6H12BN9UACTIB

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
LANOZEM HEMORRHOIDALMENTHOL, PETROLATUMSod-e Biotech Ltd34901e83-8f24-8460-e063-6394a90a27442025-05-07WarningsExact identifier
ndc (package): 84483-0010-1
ndc (product): 84483-0010
ndc11 (package): 84483001001
spl id: 34902588-135d-d432-e063-6294a90a3b86
spl set id: 34901e83-8f24-8460-e063-6394a90a2744

Reported adverse events (FAERS/openFDA)#

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