FDA.reportPublic FDA data

diaper

Manufacturer
Medek Laboratories Inc.
Effective date
2019-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:02:50

Label at a glance#

Productdiaper
Active ingredientZINC OXIDE
Label structure14 sections

Dosage and administration

change wet and soiled diapers promptly cleanse the diaper area allow to dry apply ointment liberally as often as necessary with each diaper change and anytime when exposure to wet diapers may be prolonged

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                                               Purpose

Zinc Oxide 12.8%..............................................................Skin Protectant

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

When using this product

OTC - WHEN USING SECTION

When using this product keep out of eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or does not improve after 7 days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Other Information

STORAGE AND HANDLING SECTION

protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, camellia sinensis leaf extract, tocopheryl acetate, sunflower seed extract, sorbitan oleate, bisabolol, cholesterol

Indications

INDICATIONS & USAGE SECTION

Uses

Help heal and prevent diaper rash

Protects chafed skin due to diaper rash and helps protect wetness

Do Not Use

OTC - DO NOT USE SECTION

Discontinue use if irritation occurs.

Ask a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor if condition worsens

Directions

INSTRUCTIONS FOR USE SECTION

change wet and soiled diapers promptly

cleanse the diaper area

allow to dry

apply ointment liberally as often as necessary with each diaper change and anytime when exposure to wet diapers may be prolonged

dosage

DOSAGE & ADMINISTRATION SECTION

apply ointment liberally as often as necessary with each diaper change and anytime when exposure to wet diapers may be prolonged

image of label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of labelimage of label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71969-111-012022-01-28C16284748780-1d6a99b39-d352-a426-e053-dadaa90af4c2Drug Facts
71969-111-022022-01-28C16284748780-1d6a99b39-d352-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71969-111-01diaper170 g in 1 JAROINTMENT1704
71969-111-02diaper1 in 1 PACKAGEOINTMENT14
71969-111-02diaper57 g in 1 TUBEOINTMENT574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71969-111DIAPER (ZINC OXIDE) OINTMENT [MEDEK LABORATORIES INC.]4Legacy NDC, 3 package rows20200109_38d66ea2-4c95-4a7c-88ca-d74a6d972228.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71969-11171969-111-01, 71969-111-02

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
ZINC OXIDESOI2LOH54ZACTIM
PETROLATUM4T6H12BN9UIACT
STARCH, CORNO8232NY3SJIACT
LANOLIN7EV65EAW6HIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CANDELILLA WAXWL0328HX19IACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
TOCOL ACETATE37Z972M0N0IACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
PEG-6 SORBITAN OLEATE58O7V09UCIIACT
BISABOLOL OXIDE A16AE65F94YIACT
CHOLESTEROL97C5T2UQ7JIACT

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
18a86497-ef3a-499a-aded-5145514ddfaa38d66ea2-4c95-4a7c-88ca-d74a6d9722282019-12-03WarningsExact identifier
spl id: 18a86497-ef3a-499a-aded-5145514ddfaa
spl set id: 38d66ea2-4c95-4a7c-88ca-d74a6d972228

Reported adverse events (FAERS/openFDA)#

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