FDA.reportPublic FDA data

Psodex Eczema Therapy Moisturizing Cream

Manufacturer
Psodex USA Inc.
Effective date
2021-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:49:54

Label at a glance#

ProductPsodex Eczema Therapy Moisturizing
Active ingredientOATMEAL, MINERAL OIL
Label structure8 sections

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

Active ingredient

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

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with 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 right away.

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, Borage Seed Oil, Caprylyl Glycol, Centella Asiatica Whole Extract, Cetearyl Alcohol, Cetearyl Olivate, Colloidal Oatmeal, Curcuma Longa Extract, D -Camphor Natural, D-Panthenol, Distilled Water, Ethylhexylglycerin, Fumaria Officinalis Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Isopropyl Myristate, Liquid Paraffin, Mentha Piperita Leaf Extract, Petroleum Jelly (Vasaline), Sorbitan Olivate, Stearic Acid, Tea Tree Leaf Oil, Vegetable Glycerin, Vitamin B3, Vitamin E

Questions or Comments?

OTC - QUESTIONS SECTION

1-844-PSODEXUSA info@psodexua.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73503-00473503-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
BORAGE SEED OILF8XAG1755SIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CENTELLA ASIATICA WHOLE7M867G6T1UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL OLIVATE58B69Q84JOIACT
TURMERIC856YO1Z64FIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
DEXPANTHENOL1O6C93RI7ZIACT
WATER059QF0KO0RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FUMARIA OFFICINALIS FLOWERING TOPVH659J61ZLIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MENTHA PIPERITA LEAFA389O33LX6IACT
PETROLATUM4T6H12BN9UIACT
SORBITAN OLIVATEMDL271E3GRIACT
STEARIC ACID4ELV7Z65APIACT
TEA TREE OILVIF565UC2GIACT
GLYCERINPDC6A3C0OXIACT
NIACIN2679MF687AIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
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
b8b78936-ec93-898a-e053-2a95a90a7ca7b8b7671f-1507-3b0a-e053-2995a90a3f0b2021-01-12WarningsExact identifier
spl id: b8b78936-ec93-898a-e053-2a95a90a7ca7
spl set id: b8b7671f-1507-3b0a-e053-2995a90a3f0b

Reported adverse events (FAERS/openFDA)#

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