FDA.reportPublic FDA data

Aveeno Active Naturals Eczema Therapy Itch Relief Balm

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 00:25:38

Label at a glance#

ProductAveeno Active Naturals Eczema Therapy Itch Relief Balm
Active ingredientOatmeal
Label structure12 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 or comments?

OTC - QUESTIONS SECTION

Call toll-free 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 - 17214

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aveeno®
ACTIVE NATURALS®

Eczema
Therapy

ITCH RELIEF BALM
colloidal oatmeal . skin protectant cream

helps relieve itching due to eczema, rashes,
poison ivy ,oak, sumac and insect bites

non-greasy. steroid-free .safe for daily use

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

DERMATOLOGIST
RECOMMENDED
BRAND

Net Wt. 11 Oz. (312g)

PRINCIPAL DISPLAY PANEL - 312 g Jar Label - 17214
PRINCIPAL DISPLAY PANEL - 312 g Jar Label - 17214

PRINCIPAL DISPLAY PANEL - 312 g Jar Label - 16934

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aveeno®
ACTIVE NATURALS®

Eczema
Therapy

ITCH RELIEF BALM
colloidal oatmeal . skin protectant cream

Immediate itch relief that lasts for eczema
prone skin

non-greasy. steroid-free .safe for daily use

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

DERMATOLOGIST
RECOMMENDED
BRAND

Net Wt. 11 Oz. (312g)

PRINCIPAL DISPLAY PANEL - 312 g Jar Label - 16934
PRINCIPAL DISPLAY PANEL - 312 g Jar Label - 16934

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
69968-003569968-0035-1, 69968-0035-9

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
Oatmeal8PI54V663YACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Cetostearyl Alcohol2DMT128M1SIACT
Isocetyl Alcohol1800H64066IACT
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZIACT
Benzyl AlcoholLKG8494WBHIACT
Cetyl Alcohol936JST6JCNIACT
Dimethicone92RU3N3Y1OIACT
Ethylhexylglycerin147D247K3PIACT
Sodium Cetostearyl Sulfate7ZBS06BH4BIACT
Sodium Hydroxide55X04QC32IIACT
Benzoic Acid8SKN0B0MIMIACT
p-Anisic Acid4SB6Y7DMM3IACT
Potassium Phosphate, Unspecified FormB7862WZ632IACT
Oat Kernel Oil3UVP41R77RIACT
Ceramide NP4370DF050BIACT
Stearic Acid4ELV7Z65APIACT
Citric Acid Monohydrate2968PHW8QPIACT
OatZ6J799EAJKIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT

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
53fa8d93-c84f-4950-98f9-5d5d6500f8efac76f7b7-2d70-4d3a-85a0-beeabb87db6d2019-04-17WarningsExact identifier
spl id: 53fa8d93-c84f-4950-98f9-5d5d6500f8ef
spl set id: ac76f7b7-2d70-4d3a-85a0-beeabb87db6d

Reported adverse events (FAERS/openFDA)#

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