FDA.reportPublic FDA data

Diaper Rash Cream 5.6oz

Manufacturer
China Ningbo Shangge Cosmetics Technology Corp.
Effective date
2024-09-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:19:17

Label at a glance#

ProductDiaper Rash Cream 15oz
Active ingredientZINC OXIDE
Label structure11 sections

Dosage and administration

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

Storage and handling

store at 68° to 77° F (20° to 25°C) do not use if tube seal under cap is broken or missing

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION


Zinc Oxide(40%)

Purpose

OTC - PURPOSE SECTION


Skin Protectant

Use

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


When using this product 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 with 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 cream liberally as often as necessary, with each diaper change especially at bedtime or anytime when exposure to wet diapers will be prlonged

Other information

STORAGE AND HANDLING SECTION

store at 68° to 77° F (20° to 25°C)
do not use if tube seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Petrolatum
Mineral Oil
Lanolin
Isopropyl Myristate
Beeswax
Tocopheryl Acetate
Cod Liver Oil
Aloe Barbadensis Leaf Juice

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diaper Rash Cream 5.6ozDiaper Rash Cream 5.6ozDiaper Rash Cream 15ozDiaper Rash Cream 15oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305337zinc oxide 40 % Topical CreamPSN3
1305337zinc oxide 400 MG/ML Topical CreamSCD3
1305337zinc oxide 40 % Topical CreamSY3
1305337ZNO 400 MG/ML Topical CreamSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-202-01Diaper Rash Cream 5.6oz160 g in 1 BOTTLECREAM1603
58503-205-01Diaper Rash Cream 15oz425 g in 1 JARCREAM4253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-202DIAPER RASH CREAM 15OZ (ZINC OXIDE) CREAM DIAPER RASH CREAM 5.6OZ (ZINC OXIDE) CREAM [CHINA NINGBO SHANGGE COSMETICS TECHNOLOGY CORP.]3Current NDC, 1 package rows20240912_21a7c4ce-1360-931c-e063-6294a90aa66d.zip
58503-205DIAPER RASH CREAM 15OZ (ZINC OXIDE) CREAM DIAPER RASH CREAM 5.6OZ (ZINC OXIDE) CREAM [CHINA NINGBO SHANGGE COSMETICS TECHNOLOGY CORP.]3Current NDC, 1 package rows20240912_21a7c4ce-1360-931c-e063-6294a90aa66d.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
58503-20258503-202-01
58503-20558503-205-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
YELLOW WAX2ZA36H0S2VIACT
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LANOLIN7EV65EAW6HIACT
COD LIVER OILBBL281NWFGIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
YELLOW WAX2ZA36H0S2VIACT
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LANOLIN7EV65EAW6HIACT
COD LIVER OILBBL281NWFGIACT

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
Diaper Rash Cream 5.6ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.21a7c4ce-1360-931c-e063-6294a90aa66d2024-09-11WarningsExact identifier
ndc (package): 58503-205-01
ndc (package): 58503-202-01
ndc (product): 58503-205
ndc (product): 58503-202
ndc11 (package): 58503020501
ndc11 (package): 58503020201
spl id: 21d20881-602e-a826-e063-6394a90afb45
spl set id: 21a7c4ce-1360-931c-e063-6294a90aa66d

Reported adverse events (FAERS/openFDA)#

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