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Coal Tar (Topical)


VA CLASSIFICATION
Primary: DE802
Secondary: DE500; DE900{19}

Commonly used brand name(s): Alphosyl; Aquatar; Balnetar; Balnetar Therapeutic Tar Bath; Cutar Water Dispersible Emollient Tar; DHS Tar Gel Shampoo; DHS Tar Shampoo; Denorex; Denorex Extra Strength Medicated Shampoo; Denorex Extra Strength Medicated Shampoo with Conditioners; Denorex Medicated Shampoo; Denorex Medicated Shampoo and Conditioner; Denorex Mountain Fresh Herbal Scent Medicated Shampoo; Doak Oil; Doak Oil Forte; Doak Oil Forte Therapeutic Bath Treatment; Doak Oil Therapeutic Bath Treatment For All-Over Body Care; Doak Tar Lotion; Doak Tar Shampoo; Doctar Hair & Scalp Shampoo and Conditioner; Doctar Shampoo; Estar; Fototar; Ionil T Plus; Lavatar; Liquor Carbonis Detergens; Medotar; Pentrax Anti-Dandruff Tar Shampoo; Pentrax Extra-Strength Therapeutic Tar Shampoo; PsoriNail Topical Solution; Psorigel; T-Gel; T/Derm Tar Emollient; T/Gel Therapeutic Conditioner; T/Gel Therapeutic Shampoo; Tar Doak; Taraphilic; Tarbonis; Tarpaste; Tarpaste `Doak"; Tegrin Lotion for Psoriasis; Tegrin Medicated Cream Shampoo; Tegrin Medicated Shampoo Concentrated Gel; Tegrin Medicated Shampoo Extra Conditioning Formula; Tegrin Medicated Shampoo Herbal Formula; Tegrin Medicated Shampoo Original Formula; Tegrin Medicated Soap for Psoriasis; Tegrin Skin Cream for Psoriasis; Tersa-Tar Mild Therapeutic Shampoo with Protein and Conditioner; Tersa-Tar Soapless Tar Shampoo; Tersa-Tar Therapeutic Shampoo; Theraplex T Shampoo; Zetar Emulsion; Zetar Medicated Antiseborrheic Shampoo; Zetar Shampoo.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Keratolytic (topical)—

antipsoriatic (topical)—

antiseborrheic—

Indications

Accepted

Dandruff (treatment)
Dermatitis, seborrheic (treatment){07}
Dermatitis, atopic (treatment){07}
Eczema (treatment) or{07}
Psoriasis (treatment){07}—Indicated for the relief of itching, burning, and other symptoms associated with generalized persistent dermatoses, {07} such as psoriasis, eczema, atopic dermatitis, and seborrheic dermatitis, and for the control of dandruff.
—Coal tar preparations are also used in conjunction with ultraviolet (UV) light or sunlight, under the supervision of a physician, in the treatment of psoriasis or other conditions responding to this combined therapy.


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Coal tar suppresses the hyperplastic skin in some proliferative disorders. Although there is no confirmed evidence as to its pharmacologic effects, its actions in humans have been reported as antiseptic, antipruritic, antiparasitic, antifungal, antibacterial, keratoplastic, and antiacantholic. {07} Vasoconstrictive activity has also been reported. {07}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to any of the tars may be sensitive to coal tar also. {07}

Carcinogenicity

In animal studies, coal tar has been shown to increase the incidence of epidermal carcinomas and self-limiting keratocanthomas. {07} Studies of patients with psoriasis who are treated with coal tar do not indicate an increased incidence of skin cancer. {07}

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans.

Studies have not been done in animals.

FDA Pregnancy Category C. {07}

Breast-feeding

It is not known whether coal tar is distributed into breast milk. {07} Problems in humans have not been documented.

Pediatrics

Infants—Coal tar products should not be used on infants, unless under close supervision of physician. {01}

Children—Appropriate studies on the relationship of age to the effects of this medicine have not been performed in the pediatric population.


Geriatrics


Appropriate studies on the relationship of age to the effects of this medicine have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Photosensitizing medications, other{07}    (concurrent use of coal tar with these medications may cause additive photosensitizing effects; concurrent use of coal tar with systemic or topical methoxsalen or trioxsalen is not recommended)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
» Acute inflammation, open wounds,{07} or infection of skin{07}
Sensitivity to coal tar


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Allergic or irritant{01} contact dermatitis, folliculitis, or pustular or keratocystic response{07} (skin rash)
    
skin irritation not present before therapy



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Stinging, mild —especially{01} for gel and solution dosage forms





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Coal Tar (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Allergy to coal tar or any of the other tars





Use in children—Coal tar products should not be used on infants, unless under close supervision of physician

Other medical problems, especially acute inflammation, open wounds, or infection of skin

Proper use of this medication
» Importance of not using more medication than the amount recommended

» Protecting treated area from direct sunlight for 72 hours {07} following application of medication, unless otherwise directed by physician

» Not applying medication to infected, blistered, raw, or oozing areas of skin

» Avoiding contact with the eyes

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose; not doubling doses

Proper administration

For cream and ointment dosage forms
Applying enough to cover affected area and rubbing in gently

For gel dosage form
Applying enough to cover affected area and rubbing in gently

Allowing to remain on affected area for 5 minutes, then removing excess by patting with clean tissue

For shampoo dosage form
Wetting scalp and hair with lukewarm water

Applying generous amount and rubbing into scalp, then rinsing

Applying again, working up lather, and allowing to remain on scalp for 5 minutes, then rinsing thoroughly

For nonshampoo liquid dosage forms
Applying directly to dry or wet skin or adding to lukewarm bath water, depending on product

If applying directly to skin, applying enough to cover affected area and rubbing in gently

Possibly flammable; not using near heat, open flame, or while smoking

» Proper storage

Precautions while using this medication
Medication may temporarily discolor blond, bleached, or tinted hair

» Medication may stain skin or clothing


Side/adverse effects
Signs of potential side effects, especially folliculitis, allergic or irritant contact dermatitis, pustular or keratocystic response, or skin irritation not present before therapy


General Dosing Information
After using this medication, patient should avoid exposure of treated areas to sunlamps or {07} direct sunlight for 72 hours {07} unless otherwise directed by physician, since a photosensitivity reaction may occur. {07} Before subsequent exposure to direct sunlight or sunlamps, all coal tar should be removed from patient"s skin. {07}

If coal tar is used in conjunction with ultraviolet (UV) light or sunlight, exposure to light may be undertaken 2 to 72 hours after coal tar is applied. A determination of the minimal erythemal dosage (MED) should be made for each patient and the initial irradiation should not exceed the MED. {07}

For cleansing bar dosage form
For best results on hard scales, soak in a warm {01} bath first, then lather with the cleansing bar.

For gel dosage form
If dryness occurs, an emollient may be applied 1 hour after the gel is applied and between applications as needed.

For lotion dosage form
This medication may be applied directly to dry or wet skin or added to lukewarm bath water, depending on the product.

For shampoo dosage form
The scalp should be moistened with lukewarm water, and a liberal amount of shampoo massaged into the scalp, then rinsed. Application is to be repeated and the shampoo allowed to remain on the scalp for 5 minutes, then rinsed thoroughly. The shampoo may be reapplied as necessary or as directed by the physician.

For solution dosage form
The solution may be used full strength or diluted with 3 parts of water and applied to a cotton or gauze pad and then massaged gently on the affected area.

A coal tar solution bath may be prepared by adding 4 to 6 tablespoonfuls of the solution to a tubful of lukewarm water.


Topical Dosage Forms

COAL TAR CLEANSING BAR

Usual adult and adolescent dose
Topical, to the skin, one or two times a day or as directed.

Usual pediatric dose
Dosage has not been established.

Strength(s) usually available
U.S.—


2% (coal tar extract) (OTC) [Tegrin Medicated Soap for Psoriasis{35}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For external use only.


COAL TAR CREAM

Usual adult and adolescent dose
Topical, to the skin, up to four times a day.

Usual pediatric dose
Dosage has not been established.

Strength(s) usually available
U.S.—


2% (coal tar) (OTC) [Fototar (methylparaben) (propylparaben) (stearyl alcohol)]


5% (coal tar extract) (OTC) [Alphosyl{35} ( allantoin 1.7%) (cetyl alcohol) ( lanolin alcohol) (methylparaben) ( oleyl alcohol) (propylparaben)] [Tarbonis] [Tegrin Skin Cream for Psoriasis{35} ( allantoin 1.7%) (acetylated lanolin alcohol) (alcohol SD-23A 4%) (cetyl alcohol ) (lanolin alcohol) ( stearyl alcohol)]

Canada—


5% (coal tar extract) (OTC) [Alphosyl{29} ( 2% allantoin) (cetyl alcohol) ( methylparaben 0.1%) (propylparaben 0.01%) (oleyl alcohol)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.


COAL TAR GEL

Usual adult and adolescent dose
Topical, to the skin, one or two times a day.

Usual pediatric dose
Dosage has not been established.

Strength(s) usually available
U.S.—


2.5% (coal tar extract) (OTC) [Aquatar]


5% (coal tar) (OTC) [Estar (benzyl alcohol) (SD alcohol 40 15%)]


7.5% (coal tar solution) (OTC) [Psorigel{35} ( alcohol 33%)]

Canada—


1.5% (crude coal tar) (OTC) [Psorigel (ethyl alcohol 33.3% )]


2% (coal tar extract) (OTC) [Estar (benzyl alcohol)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.


COAL TAR LOTION

Usual adult and adolescent dose
Topical, to the skin, as a direct application, as a bath, as a hand or foot soak, or as a hair rinse, depending on the product.

Usual pediatric dose
Dosage has not been established.

Strength(s) usually available
U.S.—


1.5% (coal tar) (OTC) [Cutar Water Dispersible Emollient Tar ( lanolin alcohols extract)]


1.5% (coal tar extract) (OTC) [T/Gel Therapeutic Conditioner]


5% (coal tar extract) (OTC) [Alphosyl{28}{35} (allantoin 1.7%) (cetyl alcohol) (methylparaben) (propylparaben) (SD alcohol 23A 4%)] [T/Derm Tar Emollient] [Tegrin Lotion for Psoriasis (allantoin 1.7%) (alcohol SD-23A 4%) (cetyl alcohol ) (methylparaben) (propylparaben )]


5% (tar distillate) (OTC) [Doak Tar Lotion (acetylated lanolin alcohol) (lanolin alcohol) (methylparaben) (propylparaben)]

Canada—


5% (crude coal tar extract) (OTC) [Alphosyl (cetyl alcohol) (methylparaben 0.1%) (propylparaben 0.01%)]


5% (tar distillate) (OTC) [Tar Doak (methylparaben) (propylparaben)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Shake well (depending on the product).
   • For external use only.


COAL TAR OINTMENT USP

Usual adult and adolescent dose
Topical, to the skin, two or three times a day.

Usual pediatric dose
Dosage has not been established.

Strength(s) usually available
U.S.—


1% (coal tar) (OTC) [Medotar] [Taraphilic (stearyl alcohol) (methylparaben ) (propylparaben)]


5% (tar distillate) (OTC) [Tarpaste `Doak"{35}]

Canada—


5% (tar distillate) (OTC) [Tarpaste]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For external use only.


COAL TAR SHAMPOO

Usual adult and adolescent dose
Topical, to the scalp, once a week to once a day or as directed.

Usual pediatric dose
Dosage has not been established.

Strength(s) usually available
U.S.—


0.5% (coal tar) (OTC) [DHS Tar Gel Shampoo] [DHS Tar Shampoo]


1% (whole coal tar) (OTC) [Theraplex T Shampoo{36}] [Zetar Medicated Antiseborrheic Shampoo (parachlorometaxylenol 0.5%)]


2% (crude coal tar) (OTC) [Ionil T Plus]


2% (coal tar extract) (OTC) [Doctar Hair & Scalp Shampoo and Conditioner{30}] [Doctar Shampoo] [Tegrin Medicated Shampoo Extra Conditioning Formula (SD alcohol 23-A 2.8%, methylparaben) (propylparaben)] [T/Gel Therapeutic Shampoo]


3% (tar distillate) (OTC) [Doak Tar Shampoo (isopropyl alcohol) (methylparaben) ( propylparaben)] [Tersa-Tar Soapless Tar Shampoo]


4.3% (crude coal tar) (OTC) [Pentrax Anti-Dandruff Tar Shampoo{31}]


5% (coal tar extract) (OTC) [Tegrin Medicated Shampoo Concentrated Gel (SD alcohol 23-A 4.6%) (methylparaben ) (propylparaben)] [Tegrin Medicated Shampoo Herbal Formula ( SD alcohol 23-A 4.6%) (methylparaben) (propylparaben)] [Tegrin Medicated Shampoo Original Formula (SD alcohol 23-A 4.6%) (methylparaben) ( propylparaben)]


7% (coal tar solution) (OTC) [Tegrin Medicated Cream Shampoo{36}]


9% (coal tar solution) (OTC) [Denorex Medicated Shampoo{32} (menthol 1.5%) (alcohol 7.5%)] [Denorex Medicated Shampoo and Conditioner{32} (menthol 1.5%) (alcohol 7.5%)] [Denorex Mountain Fresh Herbal Scent Medicated Shampoo{32} (menthol 1.5%) (alcohol 7.5%)]


12.5% (coal tar solution) (OTC) [Denorex Extra Strength Medicated Shampoo{32} (menthol 1.5%) ( alcohol 10.4%)] [Denorex Extra Strength Medicated Shampoo with Conditioners{32} (menthol 1.5%) (alcohol 10.4%)]

Canada—


1% (colloidal whole tar) (OTC) [Zetar Shampoo{33} ( parachlorometaxylenol 0.5%)]


1% (tar distillate) (OTC) [Tersa-Tar Mild Therapeutic Shampoo with Protein and Conditioner (methylparaben) ( propylparaben)]


2% (coal tar extract) (OTC) [T-Gel]


3% (tar distillate) (OTC) [Tersa-Tar Therapeutic Shampoo ( methylparabens) (propylparabens)]


4.3% (coal tar) (OTC) [Pentrax Extra-Strength Therapeutic Tar Shampoo]

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Shake well (depending on the product).
   • For external use only.


COAL TAR TOPICAL SOLUTION USP

Usual adult and adolescent dose
Topical, to the skin, as a direct application to wet skin or scalp or as a bath, depending on the product.

Usual pediatric dose
Dosage has not been established.

Strength(s) usually available
U.S.—


2% (tar distillate) (OTC) [Doak Oil Therapeutic Bath Treatment For All-Over Body Care (acetylated lanolin alcohol) ( lanolin alcohol)]


2.5% (coal tar) (OTC) [Balnetar Therapeutic Tar Bath]


2.5% (coal tar solution) (OTC) [PsoriNail Topical Solution{36}]


10% (tar distillate) (OTC) [Doak Oil Forte Therapeutic Bath Treatment (acetylated lanolin alcohol) (lanolin alcohol)]


25.5% (colloidal solution of tar distillate) (OTC) [Lavatar{35}]

Canada—


2% (tar distillate) (OTC) [Doak Oil{33}]


2.5% (coal tar) (OTC) [Balnetar]


7.5% (coal tar solution) (OTC) [Denorex (menthol 1.5%)]


10% (tar distillate) (OTC) [Doak Oil Forte{33}]


20% (coal tar solution) (OTC) [Liquor Carbonis Detergens{33}]


25.5% (tar distillate) (OTC) [Lavatar]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • Shake well (depending on the product).
   • For external use only.


COAL TAR TOPICAL SUSPENSION

Usual adult and adolescent dose
Topical, to the skin, as a bath.

Usual pediatric dose
Dosage has not been established.

Strength(s) usually available
U.S.—


300 mg per mL (whole coal tar) (Rx) [Zetar Emulsion{34}]

Canada—


300 mg per mL (colloidal crude coal tar) (OTC) [Zetar Emulsion{33}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Shake well.
   • For external use only.



Revised: 06/03/1994



References
  1. Panel Comments on revision dated 7/10/86, mailed 8/86, and processed 12/86.
  1. Doak Tar Lotion package insert (Doak—US), Rec 5/87, 4/88.
  1. T/Derm Emollient package insert (Neutrogena—US), Rec 5/87, 5/88.
  1. T/Gel Shampoo package insert (Neutrogena—US), Rec 5/87, 9/87, 5/88.
  1. Fototar Stik package insert (Elder—US).
  1. Fototar Cream package insert (Elder—US), Rec 5/87.
  1. Zetar Emulsion package insert (Dermik—US), Rec 3/86; Issued 1/86, Rec 5/87; Issued 1/86, Rec 4/88.
  1. DHS Shampoo and Gel Shampoo package insert (Person & Covey), Rec 5/87.
  1. Doak Oil package insert (Doak), Rec 5/87, 4/88.
  1. Doak Oil Forte package insert (Doak), Rec 5/87, 4/88.
  1. Lavatar package insert (Doak), Rec 5/87, 4/88.
  1. Tarpaste Doak package insert, Rec 5/87, 4/88.
  1. T/Gel Conditioner package insert, (Neutrogena), Rec 5/87.
  1. Tersa-Tar Shampoo package insert (TCD—Canada), Rec 5/87.
  1. Doak Tar Shampoo package insert (Doak—US), Rec 5/87, 4/88.
  1. F&C 4/86: 567, 614, 616; list of coal tar products.
  1. Open
  1. Open
  1. USAN-88.
  1. Zetar shampoo package insert (Dermik), Rec 3/86, 4/88.
  1. Taraphilic ointment package insert (Medco), Rec 5/88.
  1. Medotar ointment washable package insert (Medco), Rec 5/88.
  1. Tegrin Medicated Shampoo package insert (Reedco), Rec 4/88.
  1. Open
  1. Denorex Shampoo package insert (Whitehall), Issued 6/87, Rec 7/87.
  1. Balnetar Therapeutic Tar Bath package insert (Westwood), Rec 6/87.
  1. Open
  1. Open
  1. Open
  1. Doctar Hair & Scalp Shampoo and Conditioner package insert (Savage—US), Rec 2/91.
  1. Pentrax Anti-Dandruff Tar Shampoo package insert (Genderm—US), Rec 9/88, 12/90.
  1. PDR-OTC-91.
  1. CPS-91.
  1. PDR-91.
  1. Red Book 1991.
  1. New brand name products per Facts & Comparisons Temporary Listings, 2/91 and 4/91.
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