FDA.reportPublic FDA data

Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment

Manufacturer
Kenvue Brands LLC
Effective date
2025-02-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:56:25

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:

Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 136 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 4.8 Oz (136 g) Desitin_1Desitin_1

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
69968-0848-12024-11-25C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-22024-11-25C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-42024-11-25C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-52024-11-25C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-92024-11-25C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-12024-07-30C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-22024-07-30C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-42024-07-30C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-52024-07-30C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment
69968-0848-92024-07-30C16284748780-11e7a6dab-16aa-a2ce-e063-dadaa90aadf7Desitin Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0848-1Desitin Maximum Strength Zinc Oxide Diaper Rash454 g in 1 JARPASTE4545
69968-0848-2Desitin Maximum Strength Zinc Oxide Diaper Rash1 in 1 CARTONPASTE15
69968-0848-2Desitin Maximum Strength Zinc Oxide Diaper Rash57 g in 1 TUBEPASTE575
69968-0848-3Desitin Maximum Strength Zinc Oxide Diaper Rash136 g in 1 TUBEPASTE1365
69968-0848-3Desitin Maximum Strength Zinc Oxide Diaper Rash3 in 1 CARTONPASTE35
69968-0848-4Desitin Maximum Strength Zinc Oxide Diaper Rash1 in 1 CARTONPASTE15
69968-0848-4Desitin Maximum Strength Zinc Oxide Diaper Rash113 g in 1 TUBEPASTE1135
69968-0848-5Desitin Maximum Strength Zinc Oxide Diaper Rash1 in 1 CARTONPASTE15
69968-0848-5Desitin Maximum Strength Zinc Oxide Diaper Rash136 g in 1 TUBEPASTE1365
69968-0848-9Desitin Maximum Strength Zinc Oxide Diaper Rash28 g in 1 TUBEPASTE285
69968-0848-9Desitin Maximum Strength Zinc Oxide Diaper Rash1 in 1 CARTONPASTE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0848DESITIN MAXIMUM STRENGTH ZINC OXIDE DIAPER RASH (ZINC OXIDE) PASTE [KENVUE BRANDS LLC]5Current NDC, 11 package rows20250303_1590101a-c968-fca5-e063-6394a90a7ccc.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
69968-084869968-0848-9, 69968-0848-2, 69968-0848-4, 69968-0848-5, 69968-0848-1, 69968-0848-3

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
COD LIVER OILBBL281NWFGIACT
LANOLIN7EV65EAW6HIACT
PETROLATUM4T6H12BN9UIACT
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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentle Care KitZINC OXIDEKenvue Brands LLC4b8f7a5a-2fc4-ea00-e063-6294a90ab95b2026-02-24WarningsExact identifier
ndc (package): 69968-0848-2
ndc11 (package): 69968084802
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLC43edc287-57e1-d96e-e063-6294a90ac5a12025-11-24WarningsExact identifier
ndc (package): 69968-0848-9
ndc11 (package): 69968084809
Johnsons Baby First Touch Gift SetZINC OXIDEKenvue Brands LLC3f838eb7-42a3-c96b-e063-6294a90a74912025-09-26WarningsExact identifier
ndc (package): 69968-0848-2
ndc11 (package): 69968084802
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1590101a-c968-fca5-e063-6394a90a7ccc2025-02-28WarningsExact identifier
ndc (package): 69968-0848-3
ndc (package): 69968-0848-2
ndc (package): 69968-0848-9
ndc (package): 69968-0848-1
ndc (package): 69968-0848-4
ndc (package): 69968-0848-5
ndc (product): 69968-0848
ndc11 (package): 69968084803
ndc11 (package): 69968084804
ndc11 (package): 69968084809
ndc11 (package): 69968084801
ndc11 (package): 69968084802
ndc11 (package): 69968084805
spl id: 2f357025-248d-8fe7-e063-6294a90ad14a
spl set id: 1590101a-c968-fca5-e063-6394a90a7ccc
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLC2c2337cf-4507-7232-e063-6294a90a79c32025-01-20WarningsExact identifier
ndc (package): 69968-0848-2
ndc11 (package): 69968084802
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLC1ac59efd-9efd-09d9-e063-6394a90a5e402025-01-20WarningsExact identifier
ndc (package): 69968-0848-9
ndc11 (package): 69968084809

Reported adverse events (FAERS/openFDA)#

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