FDA.reportPublic FDA data

Diaper Rash Cream

Manufacturer
Hamilton Therapeutics, Inc
Effective date
2022-11-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:51:58

Label at a glance#

ProductDiaper Rash Cream
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose
Zinc Oxide 15% ..................................... Skin Protectant

OTC - PURPOSE SECTION

Uses Helps treat and prevent diaper rash. Protects
chafed skin due to diaper rash and helps seal out wetness.

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.

INDICATIONS & USAGE SECTION

Stop use and ask adoctor if

• condition worsens

• symptoms last more than 7 days or clear up and occur again within a few days.

WARNINGS SECTION

WarningsFor external use only.

When using this product • Avoid contact with eyes

DOSAGE & ADMINISTRATION SECTION

Directions

• Change wet and soiled diapers promptly.
• Cleanse the diaper area and allow to dry. • Apply cream liberally as often as necessary, with each diaper change,
especially at bedtime or anytime when exposure to wet diapers may be prolonged.

INACTIVE INGREDIENT SECTION

Inactive ingredients Helianthus Annuus (Sunflower) Seed Oil, Beeswax (Cera Alba), Polyhydroxystearic Acid, Butyrospermum Parkii (Shea Butter), Calophyllum Tacamahaca (Tamanu) Seed Oil, Olea Europaea (Olive) Fruit Oil, Cocos Nucifera (Coconut) Oil, Honey, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract,Tocopherol, Squalene, Sterols, Monoglycerides.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diaper Rash Cream

3.3 FL OZ / 98mL

Diaper Rash CreamDiaper Rash Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245660zinc oxide 15 % Topical CreamPSN5
245660zinc oxide 150 MG/ML Topical CreamSCD5
245660zinc oxide 15 % Topical CreamSY5
245660ZNO 150 MG/ML Topical CreamSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72381-101-012024-01-30C16284748780-11030e365-5e0f-111a-e063-dadaa90a10e2Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72381-101-01Diaper Rash Cream98 mL in 1 TUBECREAM985

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72381-101DIAPER RASH CREAM (ZINC OXIDE) CREAM [HAMILTON THERAPEUTICS, INC]5Legacy NDC, 1 package rows20221202_6e111e75-5612-69c8-e053-2a91aa0abfa8.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72381-10172381-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
ZINC OXIDESOI2LOH54ZACTIB
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SHEA BUTTERK49155WL9YIACT
COCONUT OILQ9L0O73W7LIACT
CALOPHYLLUM TACAMAHACA SEED OIL05G85L61OEIACT
OLIVE OIL6UYK2W1W1EIACT
HONEYY9H1V576FHIACT
LEMON PEEL72O054U628IACT
SAGE065C5D077JIACT
SQUALENE7QWM220FJHIACT
WHITE WAX7G1J5DA97FIACT
CHAMOMILEFGL3685T2XIACT
CITRUS AURANTIUM FLOWERO730ZX2Z83IACT
CITRUS SINENSIS FLOWERH02N5LQ5F6IACT
THYMECW657OBU4NIACT
TOCOPHEROLR0ZB2556P8IACT

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
eeb638e4-3f9a-bc42-e053-2a95a90ae06a6e111e75-5612-69c8-e053-2a91aa0abfa82022-11-30WarningsExact identifier
spl id: eeb638e4-3f9a-bc42-e053-2a95a90ae06a
spl set id: 6e111e75-5612-69c8-e053-2a91aa0abfa8

Reported adverse events (FAERS/openFDA)#

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