FDA.reportPublic FDA data

Aveeno Baby Eczema Therapy Soothing Bath Treatment

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2020-09-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:14:36

Label at a glance#

ProductAveeno Baby Eczema Therapy Soothing Bath Treatment
Active ingredientOatmeal
Label structure11 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

For dispersal in water: Turn warm water faucet on to full force. Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tub or container. Stir any colloidal oatmeal settled on the bottom. For use as a soak in a bath: Slowly sprinkle one packet in an infant tub filled with warm water. Stir any colloidal oatmeal that may have settled on the bottom. Soak affected area for 15 to 30 minutes as n...

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 43%

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

For dispersal in water:

  • Turn warm water faucet on to full force.
  • Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tub or container.
  • Stir any colloidal oatmeal settled on the bottom.

For use as a soak in a bath:

  • Slowly sprinkle one packet in an infant tub filled with warm water. Stir any colloidal oatmeal that may have settled on the bottom.
  • 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

mineral oil, calcium silicate, laureth-4

Questions?

OTC - QUESTIONS SECTION

866-4AVEENO; Outside US, dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 106 g Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEDIATRICIAN RECOMMENDED BRAND

Aveeno
Baby®
Eczema
Therapy
SOOTHING
BATH TREATMENT
colloidal oatmeal skin protectant
Steroid-free, Fragrance free, Paraben-free, Phthalate-free
Relieves Dry, Itchy, Irritated skin due to:
Rashes, Eczema, Poison Ivy/Oak/Sumac, Insect Bites
National
Eczema
Association
ACCEPTED
NATIONALECZEMA.ORG

5 Bath Packets TOTAL NET WT. 3.75 OZ. (106g)

PRINCIPAL DISPLAY PANEL - 106 g Packet Carton
PRINCIPAL DISPLAY PANEL - 106 g Packet Carton

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-019969968-0199-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Oatmeal8PI54V663YACTIB
Mineral OilT5L8T28FGPIACT
Calcium SilicateS4255P4G5MIACT
Laureth-46HQ855798JIACT

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
d43700b1-5446-4f5f-b1c4-c9a339f49bd27f689b72-ccfb-4ae0-9747-1490593998ca2020-09-18WarningsExact identifier
spl id: d43700b1-5446-4f5f-b1c4-c9a339f49bd2
spl set id: 7f689b72-ccfb-4ae0-9747-1490593998ca

Reported adverse events (FAERS/openFDA)#

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