FDA.reportPublic FDA data

MENTHOL AND ZINC OXIDE OINTMENT

Manufacturer
Delsam Pharma Llc
Effective date
2019-04-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:26:09

Label at a glance#

ProductMENTHOL AND ZINC OXIDE
Active ingredientMENTHOL, UNSPECIFIED FORM, ZINC OXIDE
Label structure10 sections

Indications and uses

A moisture barrier that prevents & helps heal skin irritation from: • urine • diarrhea • perspiration • fistula drainage • feeding tube site leakage • wound drainage (peri-wound skin) • minor burns • cuts • scrapes • itching

Dosage and administration

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Menthol and Zinc Oxide 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 15° -30°C, (59° -86°F)

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.44%

Zinc Oxide 20.6%

Purpose

OTC - PURPOSE SECTION

External analgesic / Anti-itch

Skin protectant / Anorectal astringent

Uses:

INDICATIONS & USAGE SECTION

A moisture barrier that prevents & helps heal skin irritation 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 • If condition worsens or does not improve within 7 days, consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children • In case of accidental ingestion contact a physician or poison control center immediately

Directions:

DOSAGE & ADMINISTRATION SECTION

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Menthol and Zinc Oxide 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.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

calamine, cholorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymol in a suitable ointment base

Other information:

STORAGE AND HANDLING SECTION

Store at room temperature 15° -30°C, (59° -86°F)

Questions or comments?

OTC - QUESTIONS SECTION

1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday.

SPL UNCLASSIFIED SECTION

*Compare to the active ingredient in Calmosetine® Ointment

MULTIPURPOSE MOISTURE BARRIER

PROTECTS, SOOTHES, HELPS PROMOTE HEALING

TEMPORARILY RELIVES DISCOMFORT & ITCHING

LONG-LASTING PROTECTION

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72570-113-422023-03-16C16284748780-1ab0e2407-332e-f274-e053-dbdaa90a6471MENTHOL AND ZINC OXIDE OINTMENT
72570-113-422020-09-27C16284748780-1ab0e2407-332e-f274-e053-dbdaa90a6471MENTHOL AND ZINC OXIDE OINTMENT
72570-113-422020-09-25C16284748780-1ab0e2407-332e-f274-e053-dbdaa90a6471MENTHOL AND ZINC OXIDE OINTMENT
72570-113-422020-07-22C16284748780-1ab0e2407-332e-f274-e053-dbdaa90a6471MENTHOL AND ZINC OXIDE OINTMENT

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
72570-11372570-113-42

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
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ZINC OXIDESOI2LOH54ZACTIM
FERRIC OXIDE RED1K09F3G675IACT
CHLOROTHYMOLLJ25TI0CVTIACT
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT
PHENOL339NCG44TVIACT
SODIUM BICARBONATE8MDF5V39QOIACT
THYMOL3J50XA376EIACT

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
0663237e-b277-4733-ae8e-457eb81e3ab6b5fec3cb-ca6a-4fa1-bed3-dbe86cca44992023-03-15WarningsExact identifier
spl set id: b5fec3cb-ca6a-4fa1-bed3-dbe86cca4499

Reported adverse events (FAERS/openFDA)#

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