FDA.reportPublic FDA data

Aveeno

Manufacturer
Kenvue Brands LLC
Effective date
2026-07-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-07-25 05:10:16

Label at a glance#

ProductAveeno Soothing Bath Treatment
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to Rashes Eczema Poison ivy, oak or sumac Insect bites

Dosage and administration

Turn warm water faucet on to full force Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tube or container Stir any colloidal oatmeal settled on the bottom For use as a soak in a bath: soak affected area for 15 to 30 minutes as needed, or as directed by a doctor pat dry (do not rub) to keep a thin layer on the skin.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal (100%)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to

  • Rashes
  • Eczema
  • Poison ivy, oak or sumac
  • Insect bites

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes
  • To avoid slipping, use mat in tub or shower
  • In some skin conditions, soaking too long may overdry

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

  • Turn warm water faucet on to full force
  • Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tube or container
  • Stir any colloidal oatmeal settled on the bottom
  • For use as a soak in a bath:
    • soak affected area for 15 to 30 minutes as needed, or as directed by a doctor
    • pat dry (do not rub) to keep a thin layer on the skin.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature

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 - 42 g Packet Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW LOOK

Aveeno®

Soothing Bath

Treatment

100% Colloidal Oatmeal Skin Protectant

Eczema-Prone | Sensitive Skin

Relieves itchy, irritated skin due to:

Poison Ivy, Oak, Sumac, Rashes, Insect Bites, Eczema

Soothes:

Prickly Heat, Chicken Pox, Hives, Sunburn

Natural Colloidal Oatmeal

Fragrance Free

DERMATOLOGIST RECOMMENDED BRAND

LEADER IN OAT SCIENCE

8 single use bath packets

Net wt. 1.5 oz. (42 g)

Aveeno_1Aveeno_1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130381370036401GTIN-13: 0381370036401
EAN-13: 0381370036401
GTIN-12: 381370036401
UPC-A: 381370036401
GTIN storage (14 digits): 00381370036401		Aveeno_1.jpg
QR code linkQR Code2d.kenvue.com/01/00381370036401Aveeno_1.jpg
Data codeData Matrix30063922Aveeno_1.jpg

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-040569968-0405-8

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-07-25full-release2026-06-01 01:08:54

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 Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
ndc (package): 69968-0405-8
ndc (product): 69968-0405
ndc11 (package): 69968040508
spl id: 571ba393-c5bd-266d-e063-6394a90ab27c
spl set id: 0c410b8e-025f-477c-afac-6e2e9ac88f7d

Reported adverse events (FAERS/openFDA)#

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