PSODEX PSORIASIS THERAPY INTENSIVE FORMULA- coal tar cream

Psodex Psoriasis Therapy Intensive Formula by

Drug Labeling and Warnings

Psodex Psoriasis Therapy Intensive Formula 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

Coal tar 1%

Purpose

Psoriasis cream

Use

Controls the symptoms of psoriasis

Warnings

For external use only

Whe using this product

• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
• Use caution in exposing skin to sunlight after applying this product. If may increase your tendency to sunburn up to 24 hours after application.

Do not use

• For prolonged periods of time without consulting a doctor.
• In or around the rectum or in the genital area or groin except on the advice of a doctor.
• With other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.

Ask a doctor before use if

condition covers a large area of the body

Stop use and ask a doctor if 

condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children.

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

Directions

Apply to affected areas one to four times daily or as directed by a doctor

Other information

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

Inactive ingredients

allantoin, aloe barbadensis leaf extract, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, ceteareth-20 cetearyl alcohol, curcuma longa (turmeric) extract, ethylhexylglycerin, genistein, glycerin, glyceryl stearate, glycyrrhiza glabra (licorice) root extract, hamamelis virginiana (witch hazel) oil, hydrogenated olive oil, melaleuca alternifolia (tea tree) leaf oil, mentha piperita leaf extract, menthol, panthenol (provitamin b5), phenoxyethanol, rosemary officinalis, salicylic acid, stearic acid, tocopheryl acetate (e-vitamin), water, zinc oxide.

Questions or Comments?

1-844-PSODEXUSA

Package Labeling:

INGREDIENTS AND APPEARANCE

PSODEX PSORIASIS THERAPY INTENSIVE FORMULA 
coal tar cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73503-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TURMERIC (UNII: 856YO1Z64F)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GENISTEIN (UNII: DH2M523P0H)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
WITCH HAZEL (UNII: 101I4J0U34)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
TEA TREE OIL (UNII: VIF565UC2G)
MENTHOL (UNII: L7T10EIP3A)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SALICYLIC ACID (UNII: O414PZ4LPZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73503-001-00	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	part358H	04/01/2020

Labeler - Psodex USA Inc. (076051073)