Psodex Eczema Therapy Moisturizing Cream

Psodex Eczema Therapy Moisturizing by

Drug Labeling and Warnings

Psodex Eczema Therapy Moisturizing by is a Otc medication manufactured, distributed, or labeled by Psodex USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PSODEX ECZEMA THERAPY MOISTURIZING- oatmeal, mineral cream 
Psodex USA Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Psodex Eczema Therapy Moisturizing Cream

Drug Facts

Active ingredient

Colloidal oatmeal: 0,006%

Mineral Oil: 30%

Purpose

Skin protectant cream

Use

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

• Eczema
• Rashes

Warnings

For external use only

When using this product

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

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.

Keep out of reach of children.

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

Directions

Apply as needed

Other information

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

Inactive ingredients

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?

1-844-PSODEXUSA info@psodexua.com

Package Labeling:

PSODEX ECZEMA THERAPY MOISTURIZING 
oatmeal, mineral cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73503-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.06 mg  in 1 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	300 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BORAGE SEED OIL (UNII: F8XAG1755S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
TURMERIC (UNII: 856YO1Z64F)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
PETROLATUM (UNII: 4T6H12BN9U)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARIC ACID (UNII: 4ELV7Z65AP)
TEA TREE OIL (UNII: VIF565UC2G)
GLYCERIN (UNII: PDC6A3C0OX)
NIACIN (UNII: 2679MF687A)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73503-004-01	1 in 1 BOX	03/01/2021
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2021

Labeler - Psodex USA Inc. (076051073)

Revised: 1/2021

Document Id: b8b78936-ec93-898a-e053-2a95a90a7ca7

34390-5

Set id: b8b7671f-1507-3b0a-e053-2995a90a3f0b

Version: 1

Effective Time: 20210112