80465-001-10

80465-001-10
SPL v3
SPL
SPL Set ID afd8b1a8-0b56-ec4d-e053-2a95a90a7e4c
Route
TOPICAL
Published
Effective Date 2020-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (2 g)
Inactive Ingredients
Water Ethyl Acrylate/methacrylic Acid/steareth-20 Methacrylate Copolymer Dmdm Hydantoin Propylparaben Phosphoric Acid Limonene, (+/-)- Basic Blue 1 Cocamidopropylamine Oxide Cocamidopropyl Betaine Methylparaben Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-09-21
Description

For maximum dandruff control, use every time you shampoo. Wet hair, massage unto scalp, rinse, and repeat if desired. For best results use at least twice a week or as directed by a doctor.

Medication Information

Warnings and Precautions

For external use only. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Indications and Usage

Anti-Dandruff Shampoo Helps prevent recurrence of flaking and itching associated with dandruff.

Dosage and Administration

For maximum dandruff control, use every time you shampoo.

Wet hair, massage unto scalp, rinse, and repeat if desired.

For best results use at least twice a week or as directed by a doctor.

Description

For maximum dandruff control, use every time you shampoo. Wet hair, massage unto scalp, rinse, and repeat if desired. For best results use at least twice a week or as directed by a doctor.

Section 50565-1

Keep Out of children’s reach.

Section 51727-6

Aqua, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Cocoamide DEA, Acrylates/Steareth-20 Methacrylate Copolymer, Propylene Glycol, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Methylparaben, Propylparaben, Parfum, Polyquaternium-7, Phosphoric Acid, FD&C Blue 1/ CI 42090, Limonene.

Section 51945-4

Section 55105-1

Anti-dandruff

Section 55106-9

Pyrithione Zinc 1%

Structured Label Content

Indications and Usage (34067-9)

Anti-Dandruff Shampoo Helps prevent recurrence of flaking and itching associated with dandruff.

Dosage and Administration (34068-7)

For maximum dandruff control, use every time you shampoo.

Wet hair, massage unto scalp, rinse, and repeat if desired.

For best results use at least twice a week or as directed by a doctor.

Warnings and Precautions (34071-1)

For external use only. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50565-1 (50565-1)

Keep Out of children’s reach.

Section 51727-6 (51727-6)

Aqua, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Cocoamide DEA, Acrylates/Steareth-20 Methacrylate Copolymer, Propylene Glycol, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Methylparaben, Propylparaben, Parfum, Polyquaternium-7, Phosphoric Acid, FD&C Blue 1/ CI 42090, Limonene.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-dandruff

Section 55106-9 (55106-9)

Pyrithione Zinc 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:15.789234 · Updated: 2026-03-14T23:00:37.728626