FDA.reportPublic FDA data

Swan_Simply U 965.001/965AC Eczema Soothing Moisturizing Cream

Manufacturer
Nice-Pak Products, LLC
Effective date
2026-09-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-09-11 03:02:42

Label at a glance#

ProductEczema Soothing Moisturizing Cream
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 withing 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Disclaimer

SPL UNCLASSIFIED SECTION

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

Adverse reaction

ADVERSE REACTIONS SECTION

Distributed by:

Nice-Pak Products, LLC

St. Louis, MO 63114

1-888-593-0593

Principal panel display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIMPLY U  ®

ECZEMA SOOTHING

MOISTURIZING CREAM

WITH COLLOIDAL OATMEAL

SKIN PROTECTANT

soothes dry, itchy & irritated skin resulting from eczema

steriod-free

fragrance free

Compare to Aveeno  ®Eczema Therapy Daily Moisturizing Cream

NET WT 7.3 OZ (207 g)

image descriptionimage description

Principal panel display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Swan ®

ECZEMA SOOTHING MOISTURIZING CREAM

colloidal oatmeal

skin protectant

  • Sooths dry skin, itchy, irritated skin from eczema
  • Steroid-free
  • Dermatologist tested
  • Fragrance free

Compare to Aveeno ® Eczema Therapy Moisturizing Cream*

NET WT 7.3 OZ (207 g)

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11344-96511344-965-98

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
PANTHENOLWV9CM0O67ZIACT
OAT KERNEL OIL3UVP41R77RIACT
STEARETH-20L0Q8IK9E08IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CERAMIDE 34370DF050BIACT
SODIUM CHLORIDE451W47IQ8XIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-03-13full-release2026-06-01 01:49:55

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
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
ndc (package): 11344-965-98
ndc (product): 11344-965
ndc11 (package): 11344096598
spl id: 5b0e073e-ec6e-1922-e063-6294a90ac3fc
spl set id: 23548524-2e2e-4d1a-9ebb-6f86d6279e93

Reported adverse events (FAERS/openFDA)#

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