MedPath

Baby Eczema Therapy

Gentle Steps 601.000/601AB Baby Eczema Therapy Cream

Approved
Approval ID

9720e2ad-1bcf-4023-8e92-22a962df3aad

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 18, 2025

Manufacturers
FDA

OLD EAST MAIN CO.

DUNS: 068331990

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Colloidal oatmeal

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55910-803
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Colloidal oatmeal
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 18, 2025
FDA Product Classification

INGREDIENTS (17)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DISTEARYLDIMONIUM CHLORIDEInactive
Code: OM9573ZX3X
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
OAT KERNEL OILInactive
Code: 3UVP41R77R
Classification: IACT
STEARETH-20Inactive
Code: L0Q8IK9E08
Classification: IACT
OATInactive
Code: Z6J799EAJK
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CERAMIDE NPInactive
Code: 4370DF050B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
OATMEALActive
Quantity: 10.4 kg in 1 g
Code: 8PI54V663Y
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/18/2025

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 description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/18/2025

Uses

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

  • eczema
  • rashes

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 6/18/2025

Adverse Reactions

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.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/18/2025

Active ingredient

Colloidal oatmeal 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/18/2025

Purpose

Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 6/18/2025

Warnings

For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/18/2025

When using this product

  • do not get into eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/18/2025

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

LOINC: 50565-1Updated: 6/18/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/18/2025

Directions

apply as needed

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/18/2025

disclaimer

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/18/2025

Inactive ingredients

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

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Baby Eczema Therapy - FDA Drug Approval Details