PC-TAR- coal tar shampoo 
Geritrex LLC

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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PC-TAR

Active Ingredient:
Coal Tar 1%

Purpose:

Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Intended Uses:

To provide temporary relief to itchy, dry, and/or flaky scalp conditions

Directions:

Shake well before using

Wet hair and scalp thoroughly

Massage shampoo into hair and scalp and work into a rich lather

Leave shampoo on hair for several minutes

Rinse and repeat

Rinse thoroughly with water

Warnings:

If condition covers a large part of the body, consult a physician before using this product
When using this shampoo protect the treated area from direct sunlight. It may increase your tendency to sunburn for up to 24 hours after using this product.
In rare instances hair discoloration may occur to gray, blonde, bleached, or tinted hair. 
Do not use for prolonged periods without consulting a physician.
If improvement does not occur, or condition worsens after regular use or as directed, consult a physician

FOR EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, seek prompt medical attention or contact a Poison Control Center immediately. 
Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.  

Inactive Ingredients:

Purified water, Cocamide DEA, Polysorbate 20 & 80, Cocamphocarboxy Glyceride, EDTA, Fragrance, Magnesium Aluminum Silicate, PEG-75 Lanolin, Hexeylene Glycol, Sodium Polnapthalene Sulfonate, 0.5% Parachlorometaxylenol (antimicrobial preservative)

For Questions, Comments, or Information
Call 1-800-736-3437 

image description

PC-TAR 
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR1.77441 g  in 177.441 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDE (UNII: 3YXD33R71G)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETIC ACID (UNII: 9G34HU7RV0)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
NAPHTHALENESULFONIC ACID (MIXED ISOMERS) (UNII: VZW67VII75)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-200-06177.441 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/31/2015
Labeler - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex LLC112796248manufacture(54162-200)

Revised: 7/2016
Document Id: fea138a7-b4da-45c8-bd53-815bc27aabea
Set id: 36eb2fe8-4e14-41e2-ade2-7687955c8db6
Version: 1
Effective Time: 20160705
 
Geritrex LLC