topcare™

topcare™
SPL v3
SPL
SPL Set ID 070a5249-0b37-4b7f-a55b-609a0d8504d2
Route
topical
Published
Effective Date 2024-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
coal tar (5 mg)
Inactive Ingredients
water sodium laureth-3 sulfate coco monoethanolamide cocamidopropyl betaine laureth-4 polysorbate 20 citric acid monohydrate sodium chloride edetate disodium phenoxyethanol methylchloroisothiazolinone methylisothiazolinone fd&c red no. 40 fd&c blue no. 1 fd&c yellow no. 5 fd&c yellow no. 6

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
otc monograph drug active Since 2022-08-31
Purpose

Anti-dandruff, anti-seborrheic dematitis, anti-psoriasis

Description

Drug Facts

Medication Information

Warnings

For external use only

Purpose

Anti-dandruff, anti-seborrheic dematitis, anti-psoriasis

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
Other Information
  • store away from direct sunlight
  • in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur
Inactive Ingredients

water, sodium laureth sulfate, cocamide MEA, cocamidopropyl betaine, laureth-4, fragrance, polysorbate 20, citric acid, sodium chloride, disodium EDTA, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, red 40, blue 1, yellow 5, yellow 6.

Description

Drug Facts

Use

controls the symptom of:

  • dandruff
  • seborrheic dermatitis
  • psoriasis
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Section 50569-3

Ask a doctor before use if condition covers a large part of the body.

Active Ingredient

Solubilized coal tar extract 2.0% (Coal Tar, 0.5%)

Questions Or Comments?

1-888-423-0139

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 ultra violet radiation or prescription drugs unless directed to do so by a doctor.
Principal Display Panel 251 Ml Bottle Label

NDC 76162-190-01

TopCare®

beauty

THERAPEUTIC

ANTI-DANDRUFF

SHAMPOO

with 2.5% Coal Tar

Topical Solution

(0.5% Coal Tar)

ORIGINAL STRENGTH

Fights itching & flaking

Controls the symptoms

of dandruff, psoriasis &

seborrheic dermatitis

PARABEN &

PHTHALATE FREE

8.5 FL OZ (251 mL)

05-4365A

Structured Label Content

Warnings

For external use only

Purpose

Anti-dandruff, anti-seborrheic dematitis, anti-psoriasis

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
Other Information (Other information)
  • store away from direct sunlight
  • in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur
Inactive Ingredients (Inactive ingredients)

water, sodium laureth sulfate, cocamide MEA, cocamidopropyl betaine, laureth-4, fragrance, polysorbate 20, citric acid, sodium chloride, disodium EDTA, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, red 40, blue 1, yellow 5, yellow 6.

Use

controls the symptom of:

  • dandruff
  • seborrheic dermatitis
  • psoriasis
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Section 50569-3 (50569-3)

Ask a doctor before use if condition covers a large part of the body.

Active Ingredient (Active ingredient)

Solubilized coal tar extract 2.0% (Coal Tar, 0.5%)

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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 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 ultra violet radiation or prescription drugs unless directed to do so by a doctor.
Principal Display Panel 251 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label)

NDC 76162-190-01

TopCare®

beauty

THERAPEUTIC

ANTI-DANDRUFF

SHAMPOO

with 2.5% Coal Tar

Topical Solution

(0.5% Coal Tar)

ORIGINAL STRENGTH

Fights itching & flaking

Controls the symptoms

of dandruff, psoriasis &

seborrheic dermatitis

PARABEN &

PHTHALATE FREE

8.5 FL OZ (251 mL)

05-4365A

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:19.695720 · Updated: 2026-03-14T23:10:38.535907