FDA.reportPublic FDA data

Aveeno Eczema Therapy Nighttime Itch Relief Balm

Manufacturer
Kenvue Brands LLC
Effective date
2026-02-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:37:04

Label at a glance#

ProductAveeno Eczema Therapy Nighttime Itch Relief Balm
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

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

  • • rashes
  • • eczema

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

  • protect from excessive heat (40°C/104°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

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 - 312 g Jar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW LOOK

Aveeno ®

Eczema Therapy

Nighttime Itch Relief Balm

1% Colloidal Oatmeal Skin Protectant

Eczema-Prone | Sensitive Skin

Itch relief that starts working instantly

with intense, long-lasting moisture

Colloidal Oatmeal + Ceramide

Steroid Free • Fragrance Free

ACCEPTED

e

National

Eczema

Association

DERMATOLOGIST RECOMMENDED BRAND

LEADER IN OAT SCIENCE

Net wt. 11 oz. (312 g)

Aveeno_1Aveeno_1

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130381371169344GTIN-13: 0381371169344
EAN-13: 0381371169344
GTIN-12: 381371169344
UPC-A: 381371169344
GTIN storage (14 digits): 00381371169344		Aveeno_1.jpg
QR code linkQR Code2d.kenvue.com/01/00381371169344Aveeno_1.jpg

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
69968-0772-1Aveeno Eczema Therapy Nighttime Itch Relief Balm312 g in 1 JARCREAM3124
69968-0772-2Aveeno Eczema Therapy Nighttime Itch Relief Balm28 g in 1 JARCREAM284
69968-0772-2Aveeno Eczema Therapy Nighttime Itch Relief Balm12 in 1 PACKETCREAM124

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-077269968-0772-2, 69968-0772-1

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
HEXYLDECANOL151Z7P1317IACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
BENZOIC ACID8SKN0B0MIMIACT
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZIACT
POTASSIUM PHOSPHATE, UNSPECIFIED FORMB7862WZ632IACT
P-ANISIC ACID4SB6Y7DMM3IACT
SODIUM HYDROXIDE55X04QC32IIACT
DIMETHICONE92RU3N3Y1OIACT
CETYL ALCOHOL936JST6JCNIACT
STEARIC ACID4ELV7Z65APIACT
OATZ6J799EAJKIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CERAMIDE NP4370DF050BIACT
OATMEAL8PI54V663YACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
OAT KERNEL OIL3UVP41R77RIACT

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 Nighttime Itch Relief BalmCOLLOIDAL OATMEALKenvue Brands LLCe3350a8f-b983-7c4d-e053-2a95a90a53f52026-02-04WarningsExact identifier
ndc (package): 69968-0772-2
ndc (package): 69968-0772-1
ndc (product): 69968-0772
ndc11 (package): 69968077201
ndc11 (package): 69968077202
spl id: 48e2f168-db33-94bf-e063-6294a90afb42
spl set id: e3350a8f-b983-7c4d-e053-2a95a90a53f5

Reported adverse events (FAERS/openFDA)#

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