TOPCARE THERAPEUTIC ANTI-DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS- coal tar shampoo

TopCare Therapeutic Anti-Dandruff by

Drug Labeling and Warnings

TopCare Therapeutic Anti-Dandruff by is a Otc medication manufactured, distributed, or labeled by Topco Associates, LLC, Garcoa, Inc., Sigan America, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

Purpose

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

Use

controls the symptom of:

• ⬥ dandruff
• ⬥ seborrheic dermatitis
• ⬥ psoriasis

Warnings

For external use only

Ask a doctor before use if condition covers a large part 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 ultra violet 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 right away.

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.

Questions or comments?

1-888-423-0139

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

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

INGREDIENTS AND APPEARANCE

TOPCARE THERAPEUTIC ANTI-DANDRUFF   ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-190
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Coal Tar (UNII: R533ESO2EC) (Coal Tar - UNII:R533ESO2EC)	Coal Tar	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
Coco Monoethanolamide (UNII: C80684146D)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Laureth-4 (UNII: 6HQ855798J)
Polysorbate 20 (UNII: 7T1F30V5YH)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Chloride (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)
FD&C Red No. 40 (UNII: WZB9127XOA)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
FD&C Yellow No. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-190-01	251 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M032	08/31/2022

Labeler - Topco Associates, LLC (006935977)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan America, LLC		964976968	MANUFACTURE(76162-190)