FDA.reportPublic FDA data

Aveeno ® Eczema Therapy Daily Moisturizing Cream

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:34:33

Label at a glance#

ProductAveeno Eczema Therapy daily moisturizing
Active ingredientOATMEAL
Label structure11 sections

Indications and uses

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

Dosage and administration

apply as needed

Storage and handling

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:

  • rashes
  • eczema

Warnings

WARNINGS SECTION

For external use only. 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 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

  • 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 - 206 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aveeno®

Eczema

Therapy

DAILY MOISTURIZING

CREAM

Colloidal Oatmeal Skin Protectant

Relieves

Eczema-prone skin

Clinically shown to soothe

dry, itchy, irritated skin

due to eczema

STEROID FREE

FRAGRANCE FREE

DERMATOLOGIST RECOMMENDED BRAND

COLLOIDAL OATMEAL & CERAMIDE

ACCEPTED

e

NATIONAL

ECZEMA

ASSOCIATION

net wt. 7.3 oz (206 g)

Aveeno_001Aveeno_001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN6
240651colloidal oatmeal 10 MG/ML Topical CreamSCD6
240651Avena sativa 1 % Topical CreamSY6
240651colloidal oatmeal 1 % Topical CreamSY6

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
69968-0421-1Aveeno Eczema Therapy daily moisturizing14 g in 1 TUBECREAM146
69968-0421-2Aveeno Eczema Therapy daily moisturizing354 g in 1 BOTTLE, PUMPCREAM3546
69968-0421-5Aveeno Eczema Therapy daily moisturizing141 g in 1 TUBECREAM1416
69968-0421-7Aveeno Eczema Therapy daily moisturizing206 g in 1 TUBECREAM2066

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0421AVEENO ECZEMA THERAPY DAILY MOISTURIZING (OATMEAL) CREAM [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 4 package rows20241107_dcbdb2ce-3877-41ea-9978-986e17a7c877.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
69968-042169968-0421-5, 69968-0421-7, 69968-0421-1, 69968-0421-2

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 · Source PDF

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 Eczema Therapy daily moisturizingOATMEALKenvue Brands LLCdcbdb2ce-3877-41ea-9978-986e17a7c8772024-11-05WarningsExact identifier
ndc (package): 69968-0421-2
ndc (package): 69968-0421-5
ndc (package): 69968-0421-1
ndc (package): 69968-0421-7
ndc (product): 69968-0421
ndc11 (package): 69968042105
ndc11 (package): 69968042102
ndc11 (package): 69968042107
ndc11 (package): 69968042101
spl id: 22647c2e-48f7-a1b2-e063-6394a90a5099
spl set id: dcbdb2ce-3877-41ea-9978-986e17a7c877

Reported adverse events (FAERS/openFDA)#

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