PC-TAR- coal tar shampoo

PC-TAR by

Drug Labeling and Warnings

PC-TAR by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:Coal Tar 1%

PURPOSE

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

WARNINGS AND PRECAUTIONS

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 InformationCall 1-800-736-3437 

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PC-TAR 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	1.77441 g  in 177.441 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-200-06	177.441 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/31/2015

Labeler - Geritrex LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex LLC		112796248	manufacture(54162-200)