Diaper Rash Cream 5.6oz

Manufacturer
Rejoice International Corp. | China Ningbo Shangge Cosmetics Technology Corp.
Effective date
2024-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:40

Label at a glance#

ProductDiaper Rash Cream 5.6oz
Active ingredientZINC OXIDE
Label structure8 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

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305337zinc oxide 40 % Topical CreamPSN1
1305337zinc oxide 400 MG/ML Topical CreamSCD1
1305337zinc oxide 40 % Topical CreamSY1
1305337ZNO 400 MG/ML Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-170-01Diaper Rash Cream 5.6oz160 g in 1 BOTTLECREAM1601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-170DIAPER RASH CREAM 5.6OZ (ZINC OXIDE) CREAM [REJOICE INTERNATIONAL CORP.]1Current NDC, 1 package rows20240904_2133876b-eaf0-f988-e063-6394a90aae4d.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-17057337-170-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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 OXIDERejoice International Corp.2133876b-eaf0-f988-e063-6394a90aae4d2024-09-03WarningsExact identifier
ndc (package): 57337-170-01
ndc (product): 57337-170
ndc11 (package): 57337017001
spl id: 213374ce-2597-d1eb-e063-6394a90a8ed1
spl set id: 2133876b-eaf0-f988-e063-6394a90aae4d

Reported adverse events (FAERS/openFDA)#

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