SPL v1
SPL
SPL Set ID 7cafb511-0ab7-f3b4-e053-2991aa0a2e0b
Route
TOPICAL
Published
Effective Date 2018-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Coal Tar (0.03 g)
Inactive Ingredients
Pork Collagen Isobutylparaben Water Cocamidopropyl Betaine Guar Gum Methylparaben Sodium Laureth Sulfate Butylparaben Ethylparaben Lauramidopropyl Hydroxysultaine Propylparaben Fd&c Blue No. 1 Phenoxyethanol Betaine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-03-01
Description

Active Ingredient Coal Tar 3% (from Coal Tar Topical Solution, USP 20%)

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For the temporary relief of these symptoms associated with psoriasis, seborrheic dermatitis or dandruff

  • itching
  • scaling
  • flaking
  • redness
  • irritation of the scalp.

Helps prevent recurrence.

Dosage and Administration

Directions

  • shake well before using.
  • wet hair then massage liberal amount of MG217 into the scalp and leave on for several minutes. Rinse thoroughly.
  • for best results, use at least twice a week or as directed by a physician.
Description

Active Ingredient Coal Tar 3% (from Coal Tar Topical Solution, USP 20%)

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens.
  • condition does not improve after regular use of this product as directed.
Section 50567-7

When using this product

  • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
  • use caution in exposing skin to sunlight. It may increase your tendency to sunburn for up to 24 hours after application.
  • do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed by a physician.
  • do not use for prolonged periods without consulting a physician.
Section 50569-3

Ask a doctor before use

  • if condition covers a large area of the body.
Section 51727-6

Inactive ingredients

Deionized Water, Sodium Lauryl Ether Sulfate, Cocamidopropyl Betaine, Lauramidopropyl Hydroxysultaine, Palmitic Betaine, Guar Hydroxypropyl-trimonium Chloride, Hydrolyzed Collagen, Phenoxyethanol, Methyl Paraben, n-Butyl Paraben, Ethyl Paraben, lsobutyl Paraben, Propyl Paraben, Fragrance, FD&C Blue #1

Section 51945-4

Section 53413-1

Questions? 1-800-635-3696

Section 55105-1

Purpose

Psoriasis, Seborrheic Dermatitis, Dandruff Treatment

Section 55106-9

Active Ingredient

Coal Tar 3% (from Coal Tar Topical Solution, USP 20%)

Section 60561-8

If swallowed, get medical help or contact a Poison Control Center immediately.



WARNING: This product can expose you to chemicals including Coal Tar, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of these symptoms associated with psoriasis, seborrheic dermatitis or dandruff

  • itching
  • scaling
  • flaking
  • redness
  • irritation of the scalp.

Helps prevent recurrence.

Dosage and Administration (34068-7)

Directions

  • shake well before using.
  • wet hair then massage liberal amount of MG217 into the scalp and leave on for several minutes. Rinse thoroughly.
  • for best results, use at least twice a week or as directed by a physician.
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens.
  • condition does not improve after regular use of this product as directed.
Section 50567-7 (50567-7)

When using this product

  • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
  • use caution in exposing skin to sunlight. It may increase your tendency to sunburn for up to 24 hours after application.
  • do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed by a physician.
  • do not use for prolonged periods without consulting a physician.
Section 50569-3 (50569-3)

Ask a doctor before use

  • if condition covers a large area of the body.
Section 51727-6 (51727-6)

Inactive ingredients

Deionized Water, Sodium Lauryl Ether Sulfate, Cocamidopropyl Betaine, Lauramidopropyl Hydroxysultaine, Palmitic Betaine, Guar Hydroxypropyl-trimonium Chloride, Hydrolyzed Collagen, Phenoxyethanol, Methyl Paraben, n-Butyl Paraben, Ethyl Paraben, lsobutyl Paraben, Propyl Paraben, Fragrance, FD&C Blue #1

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-800-635-3696

Section 55105-1 (55105-1)

Purpose

Psoriasis, Seborrheic Dermatitis, Dandruff Treatment

Section 55106-9 (55106-9)

Active Ingredient

Coal Tar 3% (from Coal Tar Topical Solution, USP 20%)

Section 60561-8 (60561-8)

If swallowed, get medical help or contact a Poison Control Center immediately.



WARNING: This product can expose you to chemicals including Coal Tar, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:42.490598 · Updated: 2026-03-14T22:55:20.733713