FDA.reportPublic FDA data

Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:39:03

Label at a glance#

ProductDesitin Maximum Strength Zinc Oxide Diaper Rash
Active ingredientZINC OXIDE
Label structure11 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 paste 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 at 20°C to 25°C (68°F to 77°F) • may stain clothing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 paste 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 at 20°C to 25°C (68°F to 77°F)

• may stain clothing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Petrolatum, Cod Liver Oil, Lanolin, Zea Mays (Corn) Starch, Glycerin, Beeswax, Sorbitan Sesquioleate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tocopheryl Acetate, Fragrance

Questions?

OTC - QUESTIONS SECTION

Call toll-free 800-720-3843 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 28 g Tube in a Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 CHOICE OF PEDIATRICIANS

& PARENTS

Paraben-free

Desitin ®

Maximum Strength

Paste

40% Zinc Oxide Diaper Rash Ointment

Provides powerful, long-lasting relief

NET WT 1 Oz (28 g)

DestinDestin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1797059Desitin 40 % Topical PastePSN2
1094560zinc oxide 40 % Topical PastePSN2
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD2
1094560zinc oxide 0.4 MG/MG PasteSCD2
1797059Desitin 40 % Topical PasteSY2
1094560zinc oxide 40 % PasteSY2
1094560ZNO 0.4 MG/MG PasteSY2
1797059ZNO 0.4 MG/MG Paste [Desitin]SY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69968-0768-12024-11-25C16284748780-11e7a6dab-1d19-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0768-12024-07-30C16284748780-11e7a6dab-1d19-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0768-1Desitin Maximum Strength Zinc Oxide Diaper Rash28 g in 1 TUBEPASTE282
69968-0768-1Desitin Maximum Strength Zinc Oxide Diaper Rash1 in 1 CARTONPASTE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0768DESITIN MAXIMUM STRENGTH ZINC OXIDE DIAPER RASH (ZINC OXIDE) PASTE [KENVUE BRANDS LLC]2Current NDC, 2 package rows20241127_1d5f0207-26f9-2b19-e063-6294a90a6468.zip

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
69968-076869968-0768-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
COD LIVER OILBBL281NWFGIACT
LANOLIN7EV65EAW6HIACT
STARCH, CORNO8232NY3SJIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
YELLOW WAX2ZA36H0S2VIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
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
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1d5f0207-26f9-2b19-e063-6294a90a64682024-11-14WarningsExact identifier
ndc (package): 69968-0768-1
ndc (product): 69968-0768
ndc11 (package): 69968076801
spl id: 26dcf123-a428-28f4-e063-6394a90a7575
spl set id: 1d5f0207-26f9-2b19-e063-6294a90a6468

Reported adverse events (FAERS/openFDA)#

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