PSORIASIN PROBLEM SKIN FORMULA- coal tar cream 
Alva-Amco Pharmacal Companies, 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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Psoriasin Problem Skin Formula

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.

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

PsoriasinProblemSkinPDP

PSORIASIN PROBLEM SKIN FORMULA 
coal tar cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-665
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALCOHOL (UNII: 3K9958V90M)  
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
TAMARIND JUICE (UNII: 5P6V8403U4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ARTEMISIA MONGOLICA LEAF (UNII: WY03A2288R)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
VACCINIUM CORYMBOSUM WHOLE (UNII: G1DGA0BS6T)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
CORN OIL (UNII: 8470G57WFM)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MAHONIA AQUIFOLIUM FRUITING TOP (UNII: P119855ERN)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-665-041 in 1 CARTON04/13/2018
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H04/13/201801/31/2021
Labeler - Alva-Amco Pharmacal Companies, Inc (042074856)

Revised: 10/2021
 
Alva-Amco Pharmacal Companies, Inc