FDA.reportPublic FDA data

Basics 020.002/020AD Diaper Rash Ointment 40% Zinc Oxide

Manufacturer
Amazon.com Services LLC | Nice-Pak Products, LLC
Effective date
2026-03-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:48:47

Label at a glance#

ProductZinc Oxide
Active ingredientZINC OXIDE
Label structure13 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

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, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Storage and handling

store between 20º and 25ºC (68º and 77º F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 40%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE 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

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

Other information

STORAGE AND HANDLING SECTION

store between 20º and 25ºC (68º and 77º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Desitin ®.

Adverse Reactions

ADVERSE REACTIONS SECTION

Assembled in USA with US and foreign components.

DISTRIBUTED BY: AMAZON.COM SERVICES LLC

SEATTLE, WA 98109

PAPER BOX

PLASTIC TUBE

how2recycle.info

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

amazon basics

Diaper Rash Ointment

Helps heal, soothe, and prevent diaper rash

Hypoallergenic, pediatrician and dermatologist tested

Formulated without phthalates, parabens, or dyes

Compare to Desitin ® Maximum Strength 40% Zinc Oxide Diaper Rash Paste*

40% ZINC OXIDE SKIN PROTECTANT

NET WT 4 OZ (113 g)

mm01mm01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244638zinc oxide 40 % Topical OintmentPSN2
244638zinc oxide 0.4 MG/MG Topical OintmentSCD2
244638zinc oxide 40 % Topical OintmentSY2
244638ZNO 0.4 MG/MG Topical OintmentSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-989-26Zinc Oxide113 g in 1 TUBEOINTMENT1132
72288-989-26Zinc Oxide1 in 1 CARTONOINTMENT12

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72288-98972288-989-26

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
COD LIVER OILBBL281NWFGIACT
ZINC OXIDESOI2LOH54ZACTIB
YELLOW WAX2ZA36H0S2VIACT
STARCH, CORNO8232NY3SJIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LANOLIN7EV65EAW6HIACT
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-27monthly-update2026-06-03 17:53:17

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
Zinc OxideZINC OXIDEAmazon.com Services LLC495fffd7-7b64-954a-e063-6394a90a81fd2026-03-03Warnings, Adverse reactionsExact identifier
ndc (package): 72288-989-26
ndc (product): 72288-989
ndc11 (package): 72288098926
spl id: 4c1f830a-9dd2-9a79-e063-6294a90a53cc
spl set id: 495fffd7-7b64-954a-e063-6394a90a81fd

Reported adverse events (FAERS/openFDA)#

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