PC-TAR- coal tar shampoo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)

Available from:

Geritrex LLC

INN (International Name):

COAL TAR

Composition:

COAL TAR 1.77441 g in 177.441 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis To provide temporary relief to itchy, dry, and/or flaky scalp conditions

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
----------
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
PC-TAR
coal tar shampoo
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5416 2-20 0
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CO AL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)
COAL TAR
1.774