PSODEX ECZEMA THERAPY- oatmeal, mineral cream

Psodex Eczema Therapy by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredients

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

Whe using this product

• Avoid contact with the 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 immediately.

Directions

Apply as needed

Other information

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

Inactive ingredients

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?

1-844-PSODEXUSA

Package Labeling:

INGREDIENTS AND APPEARANCE

PSODEX ECZEMA THERAPY 
oatmeal, mineral cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73503-003
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)
THIOCTIC ACID (UNII: 73Y7P0K73Y)
BORAGE SEED OIL (UNII: F8XAG1755S)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARETH-25 (UNII: 8FA93U5T67)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
OCTYLDODECANOL (UNII: 461N1O614Y)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
WATER (UNII: 059QF0KO0R)
ZINC ACETATE (UNII: FM5526K07A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73503-003-00	1 in 1 BOX	04/01/2020
1		100 mL in 1 JAR; 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	04/01/2020

Labeler - Psodex USA Inc. (076051073)