PSORIASIN PROBLEM SKIN FORMULA- coal tar cream

Psoriasin Problem Skin Formula by

Drug Labeling and Warnings

Psoriasin Problem Skin Formula by is a Otc medication manufactured, distributed, or labeled by Alva-Amco Pharmacal Companies, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Coal tar 0.5% (from Coal Tar Topical Solution, USP 20%)

Purpose

Psoriasis / Seborrheic Dermatitis Treatment

Uses

For the relief of symptoms associated with psoriasis and/or seborrheic dermatitis including itching, scaling, flaking, redness and irritation of the skin. Helps prevent recurrence.

Warnings

For external use only

Ask a doctor before use

• for prolonged periods
• if condition covers a large area of the body
• around the rectum or in the genital area or groin
• with other forms of psoriasis therapy such as ultraviolet radition or prescription drugs

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

PRECAUTIONS

Use caution in exposing skin to sunlight after applying this product, as it may increase your tendency to sunburn for up to 24 hours after application.

Warning: This product contains chemicals known to the State of California to cause cancer.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Directions

• Read all package directions and warnings before use.
• Use only as directed.
• Apply (gently massage in) a small amount of PSORIASIN to affected areas.
• Apply one to four times daily or as directed by a doctor.
• Apply to thoroughly dry skin.
• The active ingredient, coal tar, in PSORIASIN may affect very light hair color; test first on a small patch of hair before broader application to areas where light colored hair is present.
• Wash affected areas at least daily with mild soap and warm water and dry thoroughly.
• Intended for use by normally healthy adults only.
• Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.

Other information

You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Aloe barbadensis leaf juice, Artemisia mogolia leaf extract, Butylene glycol, Caprylic/capric triglyceride, Caprylyl glycol, Centella asiatica (Gotu kola) extract, Ceteareth-20, Cetearyl alcohol, Chlorphenesin, Citric acid, Cocos nucifera (coconut) oil, Disodium EDTA, Ethanol, Ginkgo biloba leaf extract, Glycerin, Glyceryl stearate, Glycyrrhiza glabra (licorice) root extract, Mahonia aquifolium (Oregon grape) extract, Phenoxyethanol, Polysorbate 80, Rosa canina fruit oil, Sodium citrate, Tamarindus indica fruit extract, Vaccinium corymbosum (Blueberry) fruit, Vitamin D3, Water and Zea mays (corn) oil.

Questions?

1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PSORIASIN PROBLEM SKIN FORMULA 
coal tar cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-665
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ARTEMISIA MONGOLICA LEAF (UNII: WY03A2288R)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
VACCINIUM CORYMBOSUM WHOLE (UNII: G1DGA0BS6T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CHLORPHENESIN (UNII: I670DAL4SZ)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CORN OIL (UNII: 8470G57WFM)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TAMARIND JUICE (UNII: 5P6V8403U4)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
COCONUT OIL (UNII: Q9L0O73W7L)
ALCOHOL (UNII: 3K9958V90M)
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
GLYCERIN (UNII: PDC6A3C0OX)
MAHONIA AQUIFOLIUM FRUITING TOP (UNII: P119855ERN)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52389-665-04	1 in 1 CARTON	04/13/2018
1		113 g in 1 TUBE; 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	04/13/2018

Labeler - Alva-Amco Pharmacal Companies, Inc (042074856)