FDA.reportPublic FDA data

Desitin Maximum Strength Zinc Oxide Diaper Rash

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:39:16

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, talc, glycerin, sorbitan sesquioleate, penta erithrityl tetra-di-t-butyl hydroxyhydrocinnamite, beeswax, tocopheryl acetate, fragrance

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed in the U.S. by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 454 g Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 CHOICE OF PEDIATRICIANS
& PARENTS

Desitin ®
Maximum Strength
40% Zinc Oxide Diaper Rash Paste

soothes and relieves on contact
clinically proven, long-lasting relief

Free from parabens, phthalates, and dyes
Hypoallergenic . Pediatrician & Dermatologist tested

  • NET WT 1 lb
    16 Oz (454 g)
Principal Display Panel - 454 g Jar Label
Principal Display Panel - 454 g Jar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1797059Desitin 40 % Topical PastePSN5
1094560zinc oxide 40 % Topical PastePSN5
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD5
1094560zinc oxide 0.4 MG/MG PasteSCD5
1797059Desitin 40 % Topical PasteSY5
1094560zinc oxide 40 % PasteSY5
1094560ZNO 0.4 MG/MG PasteSY5
1797059ZNO 0.4 MG/MG Paste [Desitin]SY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69968-0396-12024-11-25C16284748780-11e7a6dab-1f62-a2ce-e063-dadaa90aadf7Desitin ® Maximum Strength 40% Zinc Oxide Diaper Rash Paste
69968-0396-12024-07-30C16284748780-11e7a6dab-1f62-a2ce-e063-dadaa90aadf7Desitin ® Maximum Strength 40% Zinc Oxide Diaper Rash Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0396-1Desitin Maximum Strength Zinc Oxide Diaper Rash454 g in 1 JARPASTE4545

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0396DESITIN MAXIMUM STRENGTH ZINC OXIDE DIAPER RASH (ZINC OXIDE) PASTE [KENVUE BRANDS LLC]5Current NDC, Legacy NDC, 1 package rows20241127_59728810-4ea9-45a1-b945-5a54199e01f3.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
69968-039669968-0396-1

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
TALC7SEV7J4R1UIACT
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 LLC59728810-4ea9-45a1-b945-5a54199e01f32024-11-14WarningsExact identifier
ndc (package): 69968-0396-1
ndc (product): 69968-0396
ndc11 (package): 69968039601
spl id: 26e03d32-1a19-2397-e063-6394a90a8982
spl set id: 59728810-4ea9-45a1-b945-5a54199e01f3

Reported adverse events (FAERS/openFDA)#

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