FDA.reportPublic FDA data

Aveeno Eczema Therapy Itch Relief Balm

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:34:32

Label at a glance#

ProductAveeno Eczema Therapy Itch Relief Balm
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

Do not use if quality seal is broken or missing Protect from excessive heat (40°C/104°F)

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

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

  • Do not use if quality seal is broken or missing
  • Protect from excessive heat (40°C/104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Water, Cetearyl Alcohol, Isocetyl Alcohol, Dimethicone, Cetyl Alcohol, Benzyl Alcohol, Ethylhexylglycerin, Sodium Cetearyl Sulfate, Benzoic Acid, Stearic Acid, Dipotassium Phosphate, Potassium Phosphate, p-Anisic Acid, Caprylic/Capric Triglyceride, Sodium Hydroxide, Avena Sativa (Oat) Kernel Oil, Ceramide NP, Citric Acid, 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 - 312 g Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 NEW LOOK
SAME GREAT FORMULA
Aveeno ®
Eczema
Therapy

itch relief balm
colloidal oatmeal • skin protectant cream

Soothes Itchy Skin

Immediate itch relief that
lasts on eczema- prone skin
Steroid-free • fragrance-free

ACCEPTED
e
NATIONALECZEMA.ORG

 NATIONAL
 ECZEMA
 ASSOCIATION

with
COLLOIDAL
OATMEAL
& CERAMIDE

 net wt. 11 oz (312 g)

Principal Display Panel - 312 g Jar Label
Principal Display Panel - 312 g Jar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN4
240651colloidal oatmeal 10 MG/ML Topical CreamSCD4
240651Avena sativa 1 % Topical CreamSY4
240651colloidal oatmeal 1 % Topical CreamSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0419-1Aveeno Eczema Therapy Itch Relief Balm312 g in 1 JARCREAM3124
69968-0419-2Aveeno Eczema Therapy Itch Relief Balm28 g in 1 JARCREAM284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0419AVEENO ECZEMA THERAPY ITCH RELIEF BALM (OATMEAL) CREAM [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 2 package rows20241107_bab3b767-864c-4c9f-b812-4fbd2bf2ca77.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-041969968-0419-2, 69968-0419-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ISOCETYL ALCOHOL1800H64066IACT
DIMETHICONE92RU3N3Y1OIACT
CETYL ALCOHOL936JST6JCNIACT
BENZYL ALCOHOLLKG8494WBHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
BENZOIC ACID8SKN0B0MIMIACT
STEARIC ACID4ELV7Z65APIACT
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZIACT
POTASSIUM PHOSPHATE, UNSPECIFIED FORMB7862WZ632IACT
P-ANISIC ACID4SB6Y7DMM3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SODIUM HYDROXIDE55X04QC32IIACT
OAT KERNEL OIL3UVP41R77RIACT
CERAMIDE NP4370DF050BIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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 Eczema Therapy Itch Relief BalmOATMEALKenvue Brands LLCbab3b767-864c-4c9f-b812-4fbd2bf2ca772024-11-05WarningsExact identifier
ndc (package): 69968-0419-2
ndc (package): 69968-0419-1
ndc (product): 69968-0419
ndc11 (package): 69968041901
ndc11 (package): 69968041902
spl id: 21ecf099-9e6d-ed86-e063-6294a90a79a9
spl set id: bab3b767-864c-4c9f-b812-4fbd2bf2ca77

Reported adverse events (FAERS/openFDA)#

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