FDA.reportPublic FDA data

Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray

Manufacturer
Kenvue Brands LLC
Effective date
2025-02-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:55:40

Label at a glance#

ProductAveeno Baby Eczema Therapy Moisturizing Cream Clubtray
Active ingredientOATMEAL
Label structure11 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: • Eczema • Rashes

Dosage and administration

Apply as needed

Storage and handling

• To open, twist off cap and remove quality seal. • Do not use if quality seal is broken. • For use on mild to moderate eczema or as directed by a physician. • Store at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to:

• Eczema • Rashes

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product • Do not get into eyes.

OTC - STOP USE 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.

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

Apply as needed

Other information

STORAGE AND HANDLING SECTION

• To open, twist off cap and remove quality seal. • Do not use if quality seal is broken. • For use on mild to moderate eczema or as directed by a physician. • Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide NP, Sodium Chloride, Avena Sativa (Oat) Kernel Extract

Questions?

OTC - QUESTIONS SECTION

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aveeno ®

baby

eczema therapy

PEDIATRICIAN & DERMATOLOGIST RECOMMENDED BRAND

FREE OF: PARABENS, PHTHALATES, PHENOXYETHANOL, STEROIDS

clinically proven to relieve itchy,

irritated skin due to eczema

ONE (1) Aveeno® Baby eczema therapy moisturizing cream 12 FL OZ (354 mL)

and ONE (1) Aveeno® Baby eczema therapy moisturizing cream NET WT. 7.3 OZ (206 g)

Aveeno kit_1Aveeno kit_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN1
240651colloidal oatmeal 10 MG/ML Topical CreamSCD1
240651Avena sativa 1 % Topical CreamSY1
240651colloidal oatmeal 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0404-7Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray206 g in 1 TUBECREAM206 g10 mg in 1g1
69968-0921-9Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray1 in 1 CARTONKIT11
69968-0923-2Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray354 mL in 1 BOTTLECREAM354 mL10 mg in 1mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0404AVEENO BABY ECZEMA THERAPY MOISTURIZING CREAM CLUBTRAY (COLLOIDAL OATMEAL) KIT [KENVUE BRANDS LLC]1Current NDC, Legacy NDC20250223_2e04acfe-5934-dc4e-e063-6294a90ab9e6.zip
69968-0921AVEENO BABY ECZEMA THERAPY MOISTURIZING CREAM CLUBTRAY (COLLOIDAL OATMEAL) KIT [KENVUE BRANDS LLC]1Current NDC, 3 package rows20250223_2e04acfe-5934-dc4e-e063-6294a90ab9e6.zip
69968-0923AVEENO BABY ECZEMA THERAPY MOISTURIZING CREAM CLUBTRAY (COLLOIDAL OATMEAL) KIT [KENVUE BRANDS LLC]1Current NDC20250223_2e04acfe-5934-dc4e-e063-6294a90ab9e6.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
69968-092169968-0921-9
69968-092369968-0923-2
69968-040469968-0404-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARETH-20L0Q8IK9E08IACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
PETROLATUM4T6H12BN9UIACT
AVENA SATIVA (OAT) KERNEL OIL3UVP41R77RIACT
OATZ6J799EAJKIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CERAMIDE NP4370DF050BIACT
SODIUM CHLORIDE451W47IQ8XIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
OATMEAL8PI54V663YACTIB
STEARETH-20L0Q8IK9E08IACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
OATMEAL8PI54V663YACTIB
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
PETROLATUM4T6H12BN9UIACT
AVENA SATIVA (OAT) KERNEL OIL3UVP41R77RIACT
OATZ6J799EAJKIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CERAMIDE NP4370DF050BIACT
SODIUM CHLORIDE451W47IQ8XIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC2a028465-1dff-4ae7-abf6-7521c2784dd12025-09-26WarningsExact identifier
ndc (package): 69968-0404-7
ndc (product): 69968-0404
ndc11 (package): 69968040407
Aveeno Baby Eczema Therapy Moisturizing Cream ClubtrayCOLLOIDAL OATMEALKenvue Brands LLC2e04acfe-5934-dc4e-e063-6294a90ab9e62025-02-13WarningsExact identifier
ndc (package): 69968-0921-9
ndc (package): 69968-0923-2
ndc (package): 69968-0404-7
ndc (product): 69968-0921
ndc11 (package): 69968092109
ndc11 (package): 69968040407
ndc11 (package): 69968092302
spl id: 2e04ada5-93a3-dc53-e063-6294a90adfa7
spl set id: 2e04acfe-5934-dc4e-e063-6294a90ab9e6
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC2e07e83c-22dc-d644-e063-6294a90a68332025-02-13WarningsExact identifier
ndc (package): 69968-0923-2
ndc (product): 69968-0923
ndc11 (package): 69968092302

Reported adverse events (FAERS/openFDA)#

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