PSORIASIN IN-SHOWER TREATMENT- coal tar lotion/shampoo

Psoriasin In-Shower by

Drug Labeling and Warnings

Psoriasin In-Shower by is a Otc medication manufactured, distributed, or labeled by Alva-Amco Pharmacal Companies, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Coal Tar 2% (from Coal Tar Topical Solution, USP 20%)

Purpose

Psoriasis / Seborrheic Dermatitis Treatment

Uses

For the relief of symptoms of psoriasis and/or seborrheic dermatitis including itching, scaling, flaking, redness and irriation 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
• with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs

When using this product

avoid contact with the eyes. If contact occurs rinse thoroughly with water.

Stop use and ask a doctor if

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

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 cente right away.

Directions

After cleansing, apply Psoriasin In-Shower Treatment to affected areas on body and scalp. Avoid applying to bottom of feet. Leave on for at least 2 minutes, then rinse off and gently towel dry. For best results, use at least twice a week or as directed by a doctor. The active ingredient, coal tar, in Psoriasin may affect very light hair color; test first on a few strands of hair before broader application to areas where light-colored hair is present. 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 idrected by a doctor.

Other Information

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

Inactive ingredients

Aloe vera gel, capylic/capric triglycerides, cetearyl alcohol, citric acid anhydrous, Dead Sea salts, ethanol, glycerin, glyceryl stearate SE, lavender oil, myristyl alcohol, oatmeal extract, olive oil, PEG-100 stearate, petrolatum, phenoxyethanol, polysorbate 80, shea oil, stearyl alcohol, sweet almond oil, water.

Questions?

1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PSORIASIN IN-SHOWER  TREATMENT
coal tar lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-670
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CETEARYL BEHENATE (UNII: 7ARI9LTH0U)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ALMOND OIL (UNII: 66YXD4DKO9)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
OATMEAL (UNII: 8PI54V663Y)
OLIVE OIL (UNII: 6UYK2W1W1E)
PEG-100 STEARATE (UNII: YD01N1999R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEANUT OIL (UNII: O88E196QRF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52389-670-05	140 g in 1 TUBE; Type 0: Not a Combination Product	03/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	03/03/2021

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