FDA.reportPublic FDA data

Aveeno Baby Eczema Therapy Nighttime Balm

Manufacturer
Kenvue Brands LLC
Effective date
2025-03-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:56:41

Label at a glance#

ProductAveeno Baby Eczema Therapy Nighttime 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:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 28 g Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Recommended by

Pediatricians & Dermatologists

Aveeno®

baby

NET WT. 1 OZ (28 g)

eczema
therapy

nighttime balm

colloidal oatmeal skin
protectant + ceramide

clinically proven to

relieve itchy, dry, irritated

skin due to eczema

ACCEPTED

e

NATIONALECZEMA.ORG

NATIONAL

ECZEMA

ASSOCIATION

Aveeno_1Aveeno_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN7
240651colloidal oatmeal 10 MG/ML Topical CreamSCD7
240651Avena sativa 1 % Topical CreamSY7
240651colloidal oatmeal 1 % Topical CreamSY7

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0540-1Aveeno Baby Eczema Therapy Nighttime Balm312 g in 1 JARCREAM3127
69968-0540-2Aveeno Baby Eczema Therapy Nighttime Balm28 g in 1 JARCREAM287
69968-0540-5Aveeno Baby Eczema Therapy Nighttime Balm156 g in 1 JARCREAM1567

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0540AVEENO BABY ECZEMA THERAPY NIGHTTIME BALM (OATMEAL) CREAM [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 3 package rows20250308_04d90e45-c2ee-4122-b919-a0eb6d11b59a.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
69968-054069968-0540-2, 69968-0540-5, 69968-0540-1

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 Baby Eczema Therapy Nighttime BalmOATMEALKenvue Brands LLC04d90e45-c2ee-4122-b919-a0eb6d11b59a2025-03-04WarningsExact identifier
ndc (package): 69968-0540-1
ndc (package): 69968-0540-2
ndc (package): 69968-0540-5
ndc (product): 69968-0540
ndc11 (package): 69968054002
ndc11 (package): 69968054001
ndc11 (package): 69968054005
spl id: 2f7fd057-b6de-f854-e063-6394a90a1241
spl set id: 04d90e45-c2ee-4122-b919-a0eb6d11b59a

Reported adverse events (FAERS/openFDA)#

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