FDA.reportPublic FDA data

Diaper Rash Cream

Manufacturer
EllaOla Brands Inc.
Effective date
2021-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:33

Label at a glance#

ProductDiaper Rash Cream
Active ingredientZINC OXIDE
Label structure12 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin due to diaper rash Helps seal out wellness

Dosage and administration

Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposed to wet diapers may be prolonged.

Storage and handling

Store at room tempreature and protect this product from direct sunlight.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14%

Warnings

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Warnings

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.

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Warnings

OTC - STOP USE SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Copernicia Cerifera (Carnauba) Wax, Helianthus Annuus (Sunflower) Seed Oil, Laminaria Ochroleuca Extract, Polyglyceryl-2 Dipolyhydroxystearate, Ricinus Communis (Castor) Seed Oil

Uses

INDICATIONS & USAGE SECTION

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash

Helps seal out wellness

Warnings

WARNINGS SECTION

For external use only.

When using this product, do not get into eyes.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposed to wet diapers may be prolonged.

Other information

STORAGE AND HANDLING SECTION

Store at room tempreature and protect this product from direct sunlight.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers maybe be prolonged.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ellaola diaper rash cream inner pdpellaola diaper rash cream inner pdp

EllaOla Diaper Cream Tube 88mL NDC: 82057-579-01

ellaola diaper rash cream outer pdpellaola diaper rash cream outer pdp

EllaOla Diaper Cream Carton NDC: 82057-579-02

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82057-579-022023-01-30C16284748780-1f386c649-cec4-0266-e053-dadaa90a7c1ac5f2ec40-9706-621d-e053-2995a90a0eb0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82057-579-01Diaper Rash Cream88 mL in 1 TUBELOTION881
82057-579-02Diaper Rash Cream1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82057-579DIAPER RASH CREAM (ZINC OXIDE) LOTION [ELLAOLA BRANDS INC.]1Legacy NDC, 2 package rows20211001_c5f2ec40-9706-621d-e053-2995a90a0eb0.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82057-57982057-579-01, 82057-579-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
CASTOR OILD5340Y2I9GIACT
ZINC OXIDESOI2LOH54ZACTIB
CARNAUBA WAXR12CBM0EIZIACT

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
c5f2ec40-9707-621d-e053-2995a90a0eb0c5f2ec40-9706-621d-e053-2995a90a0eb02021-06-29WarningsExact identifier
spl id: c5f2ec40-9707-621d-e053-2995a90a0eb0
spl set id: c5f2ec40-9706-621d-e053-2995a90a0eb0

Reported adverse events (FAERS/openFDA)#

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