Anti-dandruff - Extra Strengtth

Anti-dandruff - Extra Strengtth
SPL v8
SPL
SPL Set ID a6fdb13b-7943-3ae9-e053-2995a90a9db5
Route
TOPICAL
Published
Effective Date 2026-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (20 mg)
Inactive Ingredients
Raphanus Sativus Var. Caudatus Root Coco Glucoside Lavandin Oil Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Polyquaternium-10 (400 Cps At 2%) Cocamidopropyl Betaine Lauric Acid Chlorphenesin Xanthan Gum Benzoic Acid Hydrogenated Palm Glycerides Disodium Cocoamphodiacetate Peppermint Oil Ascorbyl Palmitate Lavender Oil Polysorbate 20 White Pepper Coconut Acid Sodium Caproyl Lactylate Tocopherol Peg-120 Methyl Glucose Dioleate Glycerin Decyl Glucoside Polyquaternium-6 (15000 Mw) Sodium Acetate Anhydrous Propylene Glycol Formaldehyde/sodium Naphthalenesulfonate Copolymer (3000 Mw) Aloe Inga Alba Bark Lecithin, Sunflower Sodium Chloride Anhydrous Citric Acid Racementhol Glyceryl Oleate Limonene, (+/-)- Isopropyl Alcohol Water Sodium Lauroyl Lactylate Galbanum Oil Potassium Hydroxide Tea Tree Oil Butylene Glycol Phenoxyethanol Papaya Dehydroacetic Acid Methacrylic Acid - Ethyl Acrylate Copolymer (4500 Mpa.s) Eucalyptus Oil Linalool, (+/-)-

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01

Description

Zinc Pyrithione 2%

Purpose

Anti-dandruff, Ant-seborrheic dermatitis


Medication Information

Purpose

Anti-dandruff,

Ant-seborrheic dermatitis

Description

Zinc Pyrithione 2%

Uses

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

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 50567-7

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

Section 50569-3

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

Section 51945-4

414 mL NDC: 70533-004-14

60 mL NDC: 70533-004-02

Section 53413-1

Questions? 1-888-212-6855

Warnings

For external use only.

Directions

• for best results use at least twice a week or as

directed by a doctor.

• shake before use.

• wet hair, massage onto scalp, rinse, repeat if desired.

Active Ingredients

Zinc Pyrithione 2%

Inactive Ingredients

Water/Aqua/Eau, Aloe Barbadensis Leaf Juice,Cocamidopropyl Betaine, Lauric Acid, Disodium Cocoamphodiacetate, Decyl Glucoside, Polysorbate 20, Sodium Chloride, Acrylates Copolymer, Citric Acid, Glycerin, Phenoxyethanol, Polyquaternium-39, Polyquaternium-6, Coconut Acid, Mentha Piperita (Peppermint) Oil, PEG-120 Methyl Glucose Dioleate, Polyquaternium-67, Coco-Glucoside, Glyceryl Oleate, Eucalyptus Globulus Leaf Oil, Propanediol, Menthol, Raphanus Sativus (Radish) Root Extract, Lavandula Hybrida Oil, Propylene Glycol, Carica Papaya (Papaya) Fruit Extract, Chlorphenesin, Potassium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Ziziphus Joazeiro Bark Extract, Sodium Polynaphthalenesulfonate, Ferula Galbaniflua (Galbanum) Resin Oil, Xanthan Gum, Sodium Acetate, Butylene Glycol, Sodium Benzoate, Isopropyl Alcohol, Tocopherol, Hydrogenated Palm Glycerides, Lecithin, Ascorbyl Palmitate, Linalool, Limonene.


Structured Label Content

Uses

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

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 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 51945-4 (51945-4)

414 mL NDC: 70533-004-14

60 mL NDC: 70533-004-02

Section 53413-1 (53413-1)

Questions? 1-888-212-6855

Purpose

Anti-dandruff,

Ant-seborrheic dermatitis

Warnings

For external use only.

Directions

• for best results use at least twice a week or as

directed by a doctor.

• shake before use.

• wet hair, massage onto scalp, rinse, repeat if desired.

Active Ingredients

Zinc Pyrithione 2%

Inactive Ingredients (Inactive ingredients)

Water/Aqua/Eau, Aloe Barbadensis Leaf Juice,Cocamidopropyl Betaine, Lauric Acid, Disodium Cocoamphodiacetate, Decyl Glucoside, Polysorbate 20, Sodium Chloride, Acrylates Copolymer, Citric Acid, Glycerin, Phenoxyethanol, Polyquaternium-39, Polyquaternium-6, Coconut Acid, Mentha Piperita (Peppermint) Oil, PEG-120 Methyl Glucose Dioleate, Polyquaternium-67, Coco-Glucoside, Glyceryl Oleate, Eucalyptus Globulus Leaf Oil, Propanediol, Menthol, Raphanus Sativus (Radish) Root Extract, Lavandula Hybrida Oil, Propylene Glycol, Carica Papaya (Papaya) Fruit Extract, Chlorphenesin, Potassium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Ziziphus Joazeiro Bark Extract, Sodium Polynaphthalenesulfonate, Ferula Galbaniflua (Galbanum) Resin Oil, Xanthan Gum, Sodium Acetate, Butylene Glycol, Sodium Benzoate, Isopropyl Alcohol, Tocopherol, Hydrogenated Palm Glycerides, Lecithin, Ascorbyl Palmitate, Linalool, Limonene.


Advanced Ingredient Data


Raw Label Data

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