FDA.reportPublic FDA data

Gentle Steps 601.000/601AB Baby Eczema Therapy Cream

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
19
Source
full-release
Hydrated at
2026-06-01 01:48:26

Label at a glance#

ProductBaby Eczema Therapy
Active ingredientOATMEAL
Label structure13 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Other information

SPL UNCLASSIFIED SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, distearyldimonium chloride, petrolatum, isopropl palmitate, cetyl alcohol, panthenol, dimethicone, Avena sativa (oat) kernal oil, steareth-20, Avena sativa (oat) kernal extract, benzalkonium chloride, ceramide NP, sodium chloride, benzyl alcohol, sodium hydroxide

disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Aveeno Baby Eczema Therapy Moisturizing Cream.

Adverse Reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY OLD EAST MAIN CO

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

Made in the U.S.A. with U.S. and foreign parts. 

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to Aveeno ®Baby Eczema Therapy Moisturizing Cream

Gentle Steps ®

baby

eczema

therapy

cream

Colloidal Oatmeal Skin Protectant

Steroid & Fragrance Free

Helps to reduce itching and irritation associated with eczema

NET WT 5 OZ (141 g)

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-803-28Baby Eczema Therapy141 g in 1 TUBECREAM14119

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-80355910-803-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
PANTHENOLWV9CM0O67ZIACT
DIMETHICONE92RU3N3Y1OIACT
OAT KERNEL OIL3UVP41R77RIACT
STEARETH-20L0Q8IK9E08IACT
OATZ6J799EAJKIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CERAMIDE NP4370DF050BIACT
SODIUM CHLORIDE451W47IQ8XIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM HYDROXIDE55X04QC32IIACT
OATMEAL8PI54V663YACTIB

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
Baby Eczema TherapyCOLLOIDAL OATMEALOld East Main Co.9720e2ad-1bcf-4023-8e92-22a962df3aad2026-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 55910-803-28
ndc (product): 55910-803
ndc11 (package): 55910080328
spl id: 4c0fc0fd-720d-30d1-e063-6394a90afb72
spl set id: 9720e2ad-1bcf-4023-8e92-22a962df3aad

Reported adverse events (FAERS/openFDA)#

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