FDA.reportPublic FDA data

Aveeno Baby Eczema Therapy Nighttime Balm

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2020-05-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:25:18

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.

When using this product

OTC - WHEN USING SECTION

  • 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, Ethylhexylglycerin, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Ceramide NP, Caprylic/Capric Triglyceride, Sodium Cetearyl Sulfate, Potassium Phosphate, Dipotassium Phosphate, Stearic Acid, Sodium Hydroxide, Citric Acid, Benzyl Alcohol, p –Anisic Acid, Benzoic Acid.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll-free 866-4AVEENO (866-428-3366) or 215-273-8755 (collect)
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

Aveeno
Baby®

Eczema
Therapy

NIGHTTIME BALM
colloidal oatmeal . skin protectant cream

Paraben-free . Steroid-free . Fragrance-free
Relieves dry, itchy, irritated skin due to eczema

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

PEDIATRICIAN
RECOMMENDED
BRAND

NET WT. 11 OZ (312g)

PRINCIPAL DISPLAY PANEL - 312 g Jar Label
PRINCIPAL DISPLAY PANEL - 312 g Jar Label

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-002069968-0020-1, 69968-0020-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
Oatmeal8PI54V663YACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Cetostearyl Alcohol2DMT128M1SIACT
Isocetyl Alcohol1800H64066IACT
Dimethicone92RU3N3Y1OIACT
Cetyl Alcohol936JST6JCNIACT
Ethylhexylglycerin147D247K3PIACT
Oat Kernel Oil3UVP41R77RIACT
OatZ6J799EAJKIACT
Ceramide NP4370DF050BIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Sodium Cetostearyl Sulfate7ZBS06BH4BIACT
Potassium Phosphate, Unspecified FormB7862WZ632IACT
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZIACT
Stearic Acid4ELV7Z65APIACT
Sodium Hydroxide55X04QC32IIACT
Benzyl AlcoholLKG8494WBHIACT
Benzoic Acid8SKN0B0MIMIACT
Citric Acid Monohydrate2968PHW8QPIACT

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
e9905890-6984-47cf-971c-e68a93f3db0c96e81e36-5cdb-4853-9748-130f822940bf2020-05-07WarningsExact identifier
spl id: e9905890-6984-47cf-971c-e68a93f3db0c
spl set id: 96e81e36-5cdb-4853-9748-130f822940bf

Reported adverse events (FAERS/openFDA)#

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