SPL v1
SPL
SPL Set ID 7cb04d20-9b3c-27bb-e053-2a91aa0a5bc4
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
Bis-diglyceryl Polyacyladipate-2 Cholecalciferol Petrolatum .alpha.-tocopherol, D- Glyceryl Monostearate Alkyl (c12-15) Benzoate Peg/ppg-18/18 Dimethicone Peg-100 Stearate Vitamin A Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-02-01

Description

Active ingredient Coal Tar 2% (from Coal Tar Topical Solution, USP 20%)


Medication Information

Warnings and Precautions

Warnings

For external use only. Use only as directed.

Indications and Usage

Uses For the relief of these symptoms associated with psoriasis and/or seborrheic dermatitis ■ itching ■ scaling

■ flaking ■ redness ■ irritation of the skin. Helps prevent recurrence.

Dosage and Administration

Directions

Apply to affected areas 1 to 4 times daily or as directed by a physician.

Description

Active ingredient Coal Tar 2% (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 50566-9

Stop use and ask a doctor if ■ condition worsens ■ condition does not improve after regular use of this product as directed. Use caution in exposing skin to sunlight after applying this product, as it may increase your tendency to sunburn for up to 24 hours after application.

Section 50567-7

When using this product ■ Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. ■ Not recommended for use on scalp unless directed by a physician, ointment may be difficult to remove from hair.

Section 50569-3

Ask a doctor before use ■ for prolonged periods ■ if condition covers a large area of the body ■ around the rectum or in the genital area or groin ■ with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs ■ do not use for prolonged periods without consulting a physician.

Section 51727-6

Inactive ingredients

Petrolatum, C12-15 Alkyl Benzoate, Bis-Diglyceryl Polyacyladipate-2, PEG/PPG-18/18 Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Vitamin E Acetate, Vitamin A (retinyl palmitate), Vitamin D 3 (cholecalciferol)

Section 51945-4

Section 53413-1

Questions or comments? 1-800-635-3696

Section 55105-1

Purpose

Psoriasis, Seborrheic Dermatitis, Dandruff Treatment

Section 55106-9

Active ingredient

Coal Tar 2% (from Coal Tar Topical Solution, USP 20%)

Section 60561-8

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 relief of these symptoms associated with psoriasis and/or seborrheic dermatitis ■ itching ■ scaling

■ flaking ■ redness ■ irritation of the skin. Helps prevent recurrence.

Dosage and Administration (34068-7)

Directions

Apply to affected areas 1 to 4 times daily or as directed by a physician.

Warnings and Precautions (34071-1)

Warnings

For external use only. Use only as directed.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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. Use caution in exposing skin to sunlight after applying this product, as it may increase your tendency to sunburn for up to 24 hours after application.

Section 50567-7 (50567-7)

When using this product ■ Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. ■ Not recommended for use on scalp unless directed by a physician, ointment may be difficult to remove from hair.

Section 50569-3 (50569-3)

Ask a doctor before use ■ for prolonged periods ■ if condition covers a large area of the body ■ around the rectum or in the genital area or groin ■ with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs ■ do not use for prolonged periods without consulting a physician.

Section 51727-6 (51727-6)

Inactive ingredients

Petrolatum, C12-15 Alkyl Benzoate, Bis-Diglyceryl Polyacyladipate-2, PEG/PPG-18/18 Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Vitamin E Acetate, Vitamin A (retinyl palmitate), Vitamin D 3 (cholecalciferol)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-800-635-3696

Section 55105-1 (55105-1)

Purpose

Psoriasis, Seborrheic Dermatitis, Dandruff Treatment

Section 55106-9 (55106-9)

Active ingredient

Coal Tar 2% (from Coal Tar Topical Solution, USP 20%)

Section 60561-8 (60561-8)

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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