Drugplain

Coal Tar 1.39 g/100mL

Coal Tar · OINTMENT · Nopsor USA Distribution Co., Inc.

5 Recalls on Record
Plain English

Coal Tar is a ointment containing coal tar at 1.39 g/100mL, taken topical. Manufactured by Nopsor USA Distribution Co., Inc..

Key Facts

Brand Name
Coal Tar
Generic Name
Coal Tar
NDC Code (Product)
70666-016
Manufacturer
Nopsor USA Distribution Co., Inc.
Strength
1.39 g/100mL
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M032
Marketing Start
12/01/2016

Recall History

5 Recalls on Record
Class III03/16/2012

Ranbaxy Inc.

Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.

TerminatedVoluntary: Firm initiated
Class II10/09/2020

Milbar Laboratories, Inc.

GMP Deviations

TerminatedVoluntary: Firm initiated
Class III05/04/2018

Milbar Laboratories, Inc.

Subpotent

TerminatedVoluntary: Firm initiated
Class III03/09/2018

Alva-Amco Pharmacal Companies., Inc.

Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.

TerminatedVoluntary: Firm initiated
Class II03/25/2016

Reliable Rexall-A Compounding Pharmacy

Lack of Processing Controls

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

psoriasis410 reports
malaise290 reports
fatigue257 reports
pain241 reports
nasopharyngitis226 reports
skin exfoliation214 reports
fall212 reports
pyrexia212 reports
nausea210 reports
rhinorrhoea209 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use controls the symptom of: dandruff seborrheic dermatitis psoriasis

Dosage & Administration

Directions for best results use at least twice a week or as directed by a doctor wet hair thoroughly massage shampoo into the scalp lather, leave on hair and scalp for several minutes. rinse and repeat

Warnings

Warnings For external use only. Ask a doctor before using this product if condition covers a large area of the body. When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application. do not use for prolonged periods without consulting a doctor. do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Frequently Asked Questions

What is Coal Tar used for?

Coal Tar contains Coal Tar. It is a ointment taken topical. Consult your doctor for specific uses.

Is Coal Tar a controlled substance?

Coal Tar is not classified as a controlled substance by the DEA.

What is the generic name for Coal Tar?

The generic name for Coal Tar is Coal Tar. There are 12 other brand versions of Coal Tar.

What is the NDC code for Coal Tar 1.39 g/100mL?

The NDC (National Drug Code) for Coal Tar 1.39 g/100mL is 70666-016, listed by Nopsor USA Distribution Co., Inc..