FDA.reportPublic FDA data

LONAZEM

Manufacturer
PEER PHARM LTD.
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:32:19

Label at a glance#

ProductLONAZEM
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
  • When using this product

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 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.

Keep out of reach of children. 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

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

Questions or comments?

SPL UNCLASSIFIED SECTION

Contact us at lonazem.com or at Dorrington LLC, 7 Skyline Dr., Suite 350, Hawthorne, NY 10532

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2675775menthol 0.1 % / petrolatum 80 % Rectal OintmentPSN2
2675775menthol 0.001 MG/MG / petrolatum 0.8 MG/MG Rectal OintmentSCD2
2675775menthol 0.1 % / petrolatum 80 % Rectal OintmentSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1200-1LONAZEM10 in 1 CARTONOINTMENT102
69435-1200-1LONAZEM3 g in 1 TUBEOINTMENT32

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
69435-120069435-1200-1

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
MENTHOLL7T10EIP3AACTIB
PETROLATUM4T6H12BN9UACTIB
SHEA BUTTERK49155WL9YIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT

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
LONAZEMMENTHOL,PETROLATUMPEER PHARM LTD.91f7a741-4178-4639-9cd5-746a4b9a21bf2026-01-12WarningsExact identifier
ndc (package): 69435-1200-1
ndc (product): 69435-1200
ndc11 (package): 69435120001
spl id: 482ff6a4-8944-5564-e063-6294a90a6ff1
spl set id: 91f7a741-4178-4639-9cd5-746a4b9a21bf

Reported adverse events (FAERS/openFDA)#

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