FDA.reportPublic FDA data

Psodex Eczema Therapy Cream

Manufacturer
Psodex USA Inc.
Effective date
2020-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:38:05

Label at a glance#

ProductPsodex Eczema Therapy
Active ingredientOATMEAL, MINERAL OIL
Label structure8 sections

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal oatmeal: 0,006%

Mineral Oil: 30%

Purpose

OTC - PURPOSE SECTION

Skin protectant cream

Use

INDICATIONS & USAGE SECTION

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

  • Eczema
  • Rashes

Warnings

WARNINGS SECTION

For external use only

Whe using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes.
  • If contact occurs, rinse eyes thoroughly with water.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

Other information

SPL UNCLASSIFIED SECTION

Store at controlled room temperature 15° - 30°C (59° - 86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Extract Alpha Lipoic Acid, Borago Officinalis (Borage) Seed Oil, Butyrospermum Parkii (Shea) Butter,Camphor, Caprylic/Capric Triglyceride, Ceteareth-25, Cetearyl Alcohol, Glycerin, Glyceryl Stearate, Malva Sylvestris (Common Mallow) Extract, Mentha Piperita (Peppermint) Extract, Octyldodecanol, Panthenol, Phenoxyethanol, Stearic Acid, Tocopheryl Acetate, Urtica Dioica (Nettle) Extract, Water, Zinc Acetate

Questions or Comments?

OTC - QUESTIONS SECTION

1-844-PSODEXUSA

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73503-00373503-003-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
THIOCTIC ACID73Y7P0K73YIACT
BORAGE SEED OILF8XAG1755SIACT
SHEA BUTTERK49155WL9YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETEARETH-258FA93U5T67IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MENTHA PIPERITA79M2M2UDA9IACT
OCTYLDODECANOL461N1O614YIACT
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
URTICA DIOICA LEAFX6M0DRN46QIACT
WATER059QF0KO0RIACT
ZINC ACETATEFM5526K07AIACT
OATMEAL8PI54V663YACTIB
MINERAL OILT5L8T28FGPACTIB

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
9c47970e-25c9-7e97-e053-2a95a90a75b69c47ab84-66f9-ba7f-e053-2a95a90a30682020-01-16WarningsExact identifier
spl id: 9c47970e-25c9-7e97-e053-2a95a90a75b6
spl set id: 9c47ab84-66f9-ba7f-e053-2a95a90a3068

Reported adverse events (FAERS/openFDA)#

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