FDA.reportPublic FDA data

Aveeno ® baby eczema therapy moisturizing cream

Manufacturer
Kenvue Brands LLC
Effective date
2025-04-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:59:39

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:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 341g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RECOMMENDED BY

PEDIATRICIANS

& DERMATOLOGISTS

Aveeno ®

baby

eczema

therapy

moisturizing cream

colloidal oatmeal skin

protectant + vitamin B5

clinically proven to

relieve itchy, irritated

skin due to eczema

ACCEPTED

e

National

Eczema

Association

fragrance-free & steroid-free

hypoallergenic

NET WT. 12 OZ (341 g)

Aveeno_1Aveeno_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN3
240651colloidal oatmeal 10 MG/ML Topical CreamSCD3
240651Avena sativa 1 % Topical CreamSY3
240651colloidal oatmeal 1 % Topical CreamSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0901-2Aveeno Baby Eczema Therapy Moisturizing341 g in 1 BOTTLECREAM3413

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0901AVEENO BABY ECZEMA THERAPY MOISTURIZING (OATMEAL) CREAM [KENVUE BRANDS LLC]3Current NDC, 1 package rows20250426_21d2c0a0-70c3-7fd3-e063-6394a90a46d4.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
69968-090169968-0901-2

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
DIMETHICONE92RU3N3Y1OIACT
OAT KERNEL OIL3UVP41R77RIACT
STEARETH-20L0Q8IK9E08IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CERAMIDE NP4370DF050BIACT
SODIUM CHLORIDE451W47IQ8XIACT
OATZ6J799EAJKIACT
OATMEAL8PI54V663YACTIB

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
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC21d2c0a0-70c3-7fd3-e063-6394a90a46d42025-04-18WarningsExact identifier
ndc (package): 69968-0901-2
ndc (product): 69968-0901
ndc11 (package): 69968090102
spl id: 330e62bb-6834-6366-e063-6294a90a376f
spl set id: 21d2c0a0-70c3-7fd3-e063-6394a90a46d4

Reported adverse events (FAERS/openFDA)#

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