FDA.reportPublic FDA data

Menthol and Zinc Oxide Ointment – anorectal Ointment

Manufacturer
Marlex Pharmaceuticals, Inc.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:20:04

Label at a glance#

ProductMenthol and Zinc Oxide
Active ingredientMENTHOL, ZINC OXIDE
Label structure8 sections

Indications and uses

A moisture barrier that prevents & helps heal skin irritations from: Urine Diarrhea Perspiration Fistula drainage Feeding tube site leakage Wound drainage (peri-wound skin) Minor burns Cuts Scrapes Itching

Dosage and administration

Cleans with mild skin cleanser Pat dry or allow to air dry Apply a thin layer of ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Storage and handling

Store at room temperature 20°- 25° C (68°F-77°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.44%

Zinc Oxide 20.625%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

A moisture barrier that prevents & helps heal skin irritations from:

  • Urine
  • Diarrhea
  • Perspiration
  • Fistula drainage
  • Feeding tube site leakage
  • Wound drainage (peri-wound skin)
  • Minor burns
  • Cuts
  • Scrapes
  • Itching

Warnings

WARNINGS SECTION

For external use only

  • Not for deep or puncture wounds
  • Avoid contact with eyes

Stop use and ask doctor if

OTC - ASK DOCTOR SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days.

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

  • Cleans with mild skin cleanser
  • Pat dry or allow to air dry
  • Apply a thin layer of ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature 20°- 25° C (68°F-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Soft Paraffin, Isopropyl Alcohol, Hard Paraffin

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Menthol and Zinc Oxide Ointment

701-04701-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentPSN5
2123045menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCD5
2123045Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical OintmentSY5
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-701-04Menthol and Zinc Oxide113 g in 1 TUBEOINTMENT1135

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-701-04GM - Gram10135-70193de811d-14d6-4459-9966-8584cd89980512021-07-15

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10135-70110135-701-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SODIUM BICARBONATE8MDF5V39QOIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
LANOLIN7EV65EAW6HIACT
THYMOL3J50XA376EIACT
FERRIC OXIDE RED1K09F3G675IACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
PHENOL339NCG44TVIACT
ISOPROPYL ALCOHOLND2M416302IACT
MENTHOLL7T10EIP3AACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEMarlex Pharmaceuticals, Inc.c24e2dab-cab4-38f4-e053-2995a90aabae2025-12-04WarningsExact identifier
ndc (package): 10135-701-04
ndc (product): 10135-701
ndc11 (package): 10135070104
spl id: 4527ab64-b939-8e53-e063-6294a90a07a2
spl set id: c24e2dab-cab4-38f4-e053-2995a90aabae

Reported adverse events (FAERS/openFDA)#

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