SPL v2
SPL
SPL Set ID 6d3f4685-eb47-445e-86fb-3601d2c110e7
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
Water Sodium Laureth Sulfate Cocamidopropyl Betaine Lauramidopropyl Hydroxysultaine Phenoxyethanol Cetyl Betaine Guar Gum Pork Collagen Methylparaben Butylparaben Isobutylparaben Propylparaben Fd&c Blue No. 1 Ethylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-07-01

Description

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

Purpose

Psoriasis, Seborrheic Dermatitis, Dandruff Treatment


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 ofthe scalp.

Helps prevent recurrence.

Purpose

Psoriasis, Seborrheic Dermatitis, Dandruff Treatment

Description

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

Section 50565-1

Keep out of reach of children.

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

Section 51945-4

Section 60561-8

WARNING This product can gose 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

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.
Drug Facts

Active Ingredient

Coal Tar 3%

(from Coal Tar Topical Solution, USP 20%)

Questions?

1-800-635-3696

Inactive Ingredients

Deionized water, Sodium Alkyl Ether Sulfate, Cocamidopropyl Betaine, Lauramidopropyl Hydroxysultaine, Palmitic Betaine, Guar Hydroxypropyltrimonium Chloride, Hydrolyzed Collagen, Phenoxyethanol, Methyl Paraben, n-Butyl Paraben, Ethyl Paraben, Isobutyl Paraben, Propyl Paraben, Fragrance FD and C No. 1

Ask Doctor Before Use

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. 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.
Stop Use and Ask A Doctor If
  • condition worsens.
  • condition does not improve after regular use of this product as directed.

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 ofthe scalp.

Helps prevent recurrence.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 51945-4 (51945-4)

Section 60561-8 (60561-8)

WARNING This product can gose 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

Purpose

Psoriasis, Seborrheic Dermatitis, Dandruff Treatment

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.
Drug Facts

Active Ingredient

Coal Tar 3%

(from Coal Tar Topical Solution, USP 20%)

Questions?

1-800-635-3696

Inactive Ingredients (Inactive ingredients)

Deionized water, Sodium Alkyl Ether Sulfate, Cocamidopropyl Betaine, Lauramidopropyl Hydroxysultaine, Palmitic Betaine, Guar Hydroxypropyltrimonium Chloride, Hydrolyzed Collagen, Phenoxyethanol, Methyl Paraben, n-Butyl Paraben, Ethyl Paraben, Isobutyl Paraben, Propyl Paraben, Fragrance FD and C No. 1

Ask Doctor Before Use (Ask doctor before use)

if condition covers a large area of the body.

When Using This Product (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.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens.
  • condition does not improve after regular use of this product as directed.

Advanced Ingredient Data


Raw Label Data

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