MedPath

Colloidal oatmeal

CVS 965.001/965AC Eczema Soothing Moisturizing Cream

Approved
Approval ID

a153842c-d9ce-4658-912b-362a6f20b0aa

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 22, 2025

Manufacturers
FDA

CVS Pharmacy

DUNS: 062312574

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 Code69842-276
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Colloidal oatmeal
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 22, 2025
FDA Product Classification

INGREDIENTS (16)

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
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
OAT KERNEL OILInactive
Code: 3UVP41R77R
Classification: IACT
STEARETH-20Inactive
Code: L0Q8IK9E08
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CERAMIDE 3Inactive
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 mg in 1 g
Code: 8PI54V663Y
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/22/2025

principal Panel display

CVS HEALTH ®

Compare to Aveeno ®Eczema Therapy Moisturizing Cream*

Eczema

Care

MOISTURIZING CREAM

Skin protectant

  • Soothes & relieves dry, irritated, itch skin due to eczema
  • Dermatologist tested
  • Steroid free
  • Paraben & phthalate free

with Natural Colloidal Oatmeal

Fragrance free

NET WT 7.3 OZ (207 g)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/22/2025

Uses

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

  • eczema
  • rashes

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/22/2025

ADVERSE REACTION

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

©2025 CVS/pharmacy

CVS.com

1-800-SHOP CVS

CVS Quality

Money Back Guarantee

PARABEN - PHTHALATE FREE

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/22/2025

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Aveeno Eczema Therapy Daily Moisturizing Cream.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/22/2025

Active ingredient

Colloidal oatmeal 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/22/2025

Purpose

Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 5/22/2025

Warnings

For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/22/2025

When using this product

  • do not get into eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/22/2025

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: 5/22/2025

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: 5/22/2025

Directions

apply as needed

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/22/2025

Inactive ingredients

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

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