FDA.reportPublic FDA data

Aveeno Baby ® Eczema Therapy MOISTURIZING CREAM

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2019-04-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:25:34

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

Call toll-free 866-4AVEENO or 215-273-8755 (collect) or visit www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed in the US by:

JOHNSON & JOHNSON
CONSUMER PRODUCTS
COMPANY

Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 206 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEDIATRICIAN
RECOMMENDED BRAND

Aveeno
Baby®
Eczema
Therapy
MOISTURIZING CREAM
colloidal oatmeal . skin protectant

Relieves dry, itchy, irritated skin
due to eczema
Clinically shown to soothe babies
with eczema

Steroid-free, Fragrance-free
Paraben-free,Phthalate-free

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

NET WT. 7.3 OZ. (206g)

PRINCIPAL DISPLAY PANEL - 206 g Tube Label
PRINCIPAL DISPLAY PANEL - 206 g Tube Label

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
69968-003669968-0036-5, 69968-0036-7, 69968-0036-2, 69968-0036-9

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
Oatmeal8PI54V663YACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
PanthenolWV9CM0O67ZIACT
Distearyldimonium ChlorideOM9573ZX3XIACT
Petrolatum4T6H12BN9UIACT
Isopropyl Palmitate8CRQ2TH63MIACT
Cetyl Alcohol936JST6JCNIACT
Dimethicone92RU3N3Y1OIACT
Oat Kernel Oil3UVP41R77RIACT
Steareth-20L0Q8IK9E08IACT
Benzalkonium ChlorideF5UM2KM3W7IACT
Ceramide NP4370DF050BIACT
Sodium Chloride451W47IQ8XIACT
OatZ6J799EAJKIACT

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
d69d6264-8c50-43b2-b2f7-b60e1a85361e118ed2e4-73f1-46ed-8299-a615e68752632019-04-17WarningsExact identifier
spl id: d69d6264-8c50-43b2-b2f7-b60e1a85361e
spl set id: 118ed2e4-73f1-46ed-8299-a615e6875263

Reported adverse events (FAERS/openFDA)#

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