SPL v2
SPL
SPL Set ID 9aeada50-2cb2-d113-126a-ddcf05f817b6
Route
TOPICAL
Published
Effective Date 2021-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (250 mg)
Inactive Ingredients
Water Glycerin Propylene Glycol Mineral Oil Lanolin Acetic Monoethanolamide Cetyl Alcohol Cetostearyl Alcohol Polysorbate 60 Yellow Wax Wheat Germ Oil Olive Oil Jojoba Oil Menthol, Unspecified Form Camphor (synthetic) Eucalyptus Oil Aloe Vera Leaf Dimethicone .alpha.-tocopherol Acetate Vitamin A Palmitate Stearalkonium Chloride Polyquaternium-11 (1000000 Mw) Biotin Rosemary Equisetum Arvense Branch Hops Lemon Peel Sodium Borate Dmdm Hydantoin Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-11-01

Description

Pyrithione Zinc 0.25%

Purpose

Anti-Dandruff


Medication Information

Purpose

Anti-Dandruff

Description

Pyrithione Zinc 0.25%

Use

Controls the symptoms of dandruff

Section 42229-5

AFAM CONCEPT, INC.

Chicago, IL 60629

London NW 10 6JH

UK

(800) 262-2326

(773) 838-1336

Registered # 1,387,930

Section 50565-1

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

Warnings

For external use only

Ask a doctor before use if you have a condition that covers a large area of the body.

When using this product avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

Stop use and ask adoctor if condition worsens or dowes not improve after regular use of this product as directed.

Packaging

Drug Facts

Directions:

For best results apply to affected areas one to four times daily or as directed by a doctor. Spread a small amount in the palms of your hands and apply evenly to the scalp and entire head of hair. Style as desired.

Active Ingredient

Pyrithione Zinc 0.25%

Inactive Ingredients

Water (Aqua), Glycerin, Propylene Glycol, Mineral Oil (Paraffinum Liquidum), Lanolin, Acetamide MEA, Cetyl Alcohol, Cetearyl Alcohol, Polysorbate 60, Beeswax, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Menthol, Camphor, Eucalyptus Globulus Leaf Oil, Aloe Barbadensis Leaf Juice, Dimethicone, Tocopherol Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Stearalkonium Chloride, Polyquaternium-11, Biotin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Equisetum Arvense Extract, Humulus Lupulus (Hops) Extract, Citrus Medica Limonum, (Lemon) Peel Extract, Sodium Borate, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance, (Parfum)


Structured Label Content

Use

Controls the symptoms of dandruff

Section 42229-5 (42229-5)

AFAM CONCEPT, INC.

Chicago, IL 60629

London NW 10 6JH

UK

(800) 262-2326

(773) 838-1336

Registered # 1,387,930

Section 50565-1 (50565-1)

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

Purpose

Anti-Dandruff

Warnings

For external use only

Ask a doctor before use if you have a condition that covers a large area of the body.

When using this product avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

Stop use and ask adoctor if condition worsens or dowes not improve after regular use of this product as directed.

Packaging

Drug Facts

Directions:

For best results apply to affected areas one to four times daily or as directed by a doctor. Spread a small amount in the palms of your hands and apply evenly to the scalp and entire head of hair. Style as desired.

Active Ingredient

Pyrithione Zinc 0.25%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Propylene Glycol, Mineral Oil (Paraffinum Liquidum), Lanolin, Acetamide MEA, Cetyl Alcohol, Cetearyl Alcohol, Polysorbate 60, Beeswax, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Menthol, Camphor, Eucalyptus Globulus Leaf Oil, Aloe Barbadensis Leaf Juice, Dimethicone, Tocopherol Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Stearalkonium Chloride, Polyquaternium-11, Biotin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Equisetum Arvense Extract, Humulus Lupulus (Hops) Extract, Citrus Medica Limonum, (Lemon) Peel Extract, Sodium Borate, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance, (Parfum)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)