FDA.reportPublic FDA data

Aveeno ® baby eczema therapy moisturizing cream

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 00:55:12

Label at a glance#

ProductAveeno Baby Eczema Therapy Moisturizing
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

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

Drug Facts

Active ingredient

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.

When using this product

OTC - WHEN USING SECTION

  • 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 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

  • 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 - 354 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RECOMMENDED BY

PEDIATRICIANS

& DERMATOLOGISTS

Aveeno®

baby

NEW

LOOK

Same Great

Formula

eczema

therapy

moisturizing cream

colloidal oatmeal skin

protectant + vitamin B5

clinically proven to

relieve itchy, irritated

skin due to eczema

ACCEPTED

e

NATIONALECZEMA.ORG

National

Eczema

Association

fragrance-free & steroid-free

hypoallergenic

12 FL OZ (354 mL)

Aveeno_01Aveeno_01

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
69968-0923-2Aveeno Baby Eczema Therapy Moisturizing354 mL in 1 BOTTLECREAM3541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0923AVEENO BABY ECZEMA THERAPY MOISTURIZING (OATMEAL) CREAM [KENVUE BRANDS LLC]1Current NDC, 1 package rows20250215_2e07e83c-22dc-d644-e063-6294a90a6833.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-092369968-0923-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Baby Eczema Therapy Moisturizing Cream ClubtrayCOLLOIDAL OATMEALKenvue Brands LLC2e04acfe-5934-dc4e-e063-6294a90ab9e62025-02-13WarningsExact identifier
ndc (package): 69968-0923-2
ndc11 (package): 69968092302
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
spl id: 2e07e828-b377-0232-e063-6394a90a884f
spl set id: 2e07e83c-22dc-d644-e063-6294a90a6833

Reported adverse events (FAERS/openFDA)#

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