Topcare Medicated Shampoo-76162-171-11

Topcare Medicated Shampoo-76162-171-11
SPL v4
SPL
SPL Set ID ecf87660-f552-1f6b-e053-2a95a90a2486
Route
TOPICAL
Published
Effective Date 2023-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Selenium Sulfide (10 mg)
Inactive Ingredients
Sodium Laureth Sulfate Ammonium Chloride Water Triethanolamine Lauryl Sulfate Cocamidopropyl Betaine Magnesium Aluminum Silicate Citric Acid Monohydrate Fragrance Clean Orc0600327 Magnesium Aluminum Silicate Type Ia Hypromellose, Unspecified Methylisothiazolinone Fd&c Blue No. 1 Methacrylic Acid - Ethyl Acrylate Copolymer (4500 Mpa.s) Methylchloroisothiazolinone Menthol Sodium Hydroxide D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-04

Description

Selenium Sulfide 1%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of recurrence.

Dosage and Administration

■ shake well, wet hair, massage onto scalp and rinse.

■ for best results, use at least twice a week or as directed by a doctor.

Description

Selenium Sulfide 1%

Section 44425-7

store at room temperature.

Section 50565-1

Keep out of reach of children.In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Section 50566-9

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

Section 50567-7

■ avoid contact with eyes. If contact occurs, rinse thoroughly with water.

■ for use on color treated or permed hair, rinse thoroughly.

Section 50569-3

Ask a doctor before useif you have seborrheic dermatitis in areas other than the scalp.

Section 51727-6

Water (Aqua), Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Citric Acid,

Fragrance (Parfum), Ammonium Chloride, Menthol, Sodium Hydroxide, Magnesium Aluminum Silicate, Hydroxypropyl Methylcellulose,

Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Section 51945-4

Section 53413-1

1-888-423-0139

Section 55105-1

anti dandruff

Section 55106-9

Selenium Sulfide 1%


Structured Label Content

Indications and Usage (34067-9)

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of recurrence.

Dosage and Administration (34068-7)

■ shake well, wet hair, massage onto scalp and rinse.

■ for best results, use at least twice a week or as directed by a doctor.

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

store at room temperature.

Section 50565-1 (50565-1)

Keep out of reach of children.In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

■ avoid contact with eyes. If contact occurs, rinse thoroughly with water.

■ for use on color treated or permed hair, rinse thoroughly.

Section 50569-3 (50569-3)

Ask a doctor before useif you have seborrheic dermatitis in areas other than the scalp.

Section 51727-6 (51727-6)

Water (Aqua), Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Citric Acid,

Fragrance (Parfum), Ammonium Chloride, Menthol, Sodium Hydroxide, Magnesium Aluminum Silicate, Hydroxypropyl Methylcellulose,

Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-888-423-0139

Section 55105-1 (55105-1)

anti dandruff

Section 55106-9 (55106-9)

Selenium Sulfide 1%


Advanced Ingredient Data


Raw Label Data

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