MG217 PSORIASIS MEDICATED MULTI-SYMPTOM- coal tar ointment 
Wisconsin Pharmacal Company

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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Active ingredient

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

Purpose

Psoriasis, Seborrheic Dermatitis, Dandruff Treatment

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

Warnings
For external use only. Use only as directed.

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 radiation or prescription drugs ■ do not use for prolonged periods without consulting a physician.

When using this product ■ Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. ■ Not recommended for use on scalp unless directed by a physician, ointment may be difficult to remove from hair.

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

WARNING: This product can expose you to chemicals including Coal Tar, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

Directions
Apply to affected areas 1 to 4 times daily or as directed by a physician.

Inactive ingredients
Petrolatum, C12-15 Alkyl Benzoate, Bis-Diglyceryl Polyacyladipate-2, PEG/PPG-18/18 Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Vitamin E Acetate, Vitamin A (retinyl palmitate), Vitamin D 3 (cholecalciferol)

Questions or comments? 1-800-635-3696

Labelcarton

MG217 PSORIASIS  MEDICATED MULTI-SYMPTOM
coal tar ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68093-7233
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
PETROLATUM (UNII: 4T6H12BN9U)  
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
PEG-100 STEARATE (UNII: YD01N1999R)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68093-7233-11 in 1 CARTON02/01/2018
1107 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H02/01/2018
Labeler - Wisconsin Pharmacal Company (800873986)
Registrant - Wisconsin Pharmacal Company (800873986)
Establishment
NameAddressID/FEIBusiness Operations
Wisconsin Pharmacal Company800873986manufacture(68093-7233)

Revised: 12/2018
Document Id: 7cb04d20-9b3d-27bb-e053-2a91aa0a5bc4
Set id: 7cb04d20-9b3c-27bb-e053-2a91aa0a5bc4
Version: 1
Effective Time: 20181210
 
Wisconsin Pharmacal Company