SPL v1
SPL
SPL Set ID 3376b104-1f07-fab3-e063-6394a90a0ca4
Route
TOPICAL
Published
Effective Date 2025-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.02 g) Zinc Pyrithione (0.01 g)
Inactive Ingredients
Stemona Tuberosa Root Bassia Scoparia Fruit Cnidium Monnieri Fruit Zingiber Officinale Whole Platycladus Orientalis Leaf Sauromatum Giganteum Whole Reynoutria Multiflora Root Mentha Canadensis Whole Dryobalanops Aromatica Resin Gleditsia Sinensis Fruit

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-22

Description

Active ingredient: Zinc Pyrithione 1% Salicylic Acid 2%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses:

  • Controls dandruff, flaking, and itching
  • Helps relieve symptoms of seborrheic dermatitis
  • Clears scalp buildup and supports healthy scalp environment
Dosage and Administration

Directions:

  • Shake well before use
  • Apply to wet scalp
  • Gently massage and leave on for 3-5 minutes
  • Rinse thoroughly
  • Use 2-3 times weekly, or as directed by your dermatologist
Description

Active ingredient: Zinc Pyrithione 1% Salicylic Acid 2%

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

Section 50567-7

When using this product

• Avoid contact with eyes. If contact occurs, rinse thoroughly.

Section 50569-3

Ask a doctor before use if you have:

• Sensitive skin

Section 50570-1

On broken or irritated skin.

Section 51727-6

Inactive ingredients:

  • Salicylic Acid
  • Zinc Pyrithione
  • Stemona Tuberosa Root
  • Bassia Scoparia Fruit
  • Zingiber Officinale Whole
  • Platycladus Orientalis Leaf
  • Sauromatum Giganteum Whole
  • Reynoutria Multiflora Root
  • Mentha Canadensis Whole
  • Dryobalanops Aromatica Resin
  • Gleditsia Sinensis Fruit
  • Cnidium Monnieri Fruit

Section 53413-1

Questions or comments?

Contact us at [email protected]

Section 53414-9

If pregnant or breast-feeding

• Ask a health professional before use

Section 55105-1

  • Purpose 1: Anti-Dandruff ( Active ingredient:Zinc Pyrithione 1% )
  • Purpose 2: Anti-seborrheic dermatitis ( Active ingredient:Salicylic Acid 2% )
Section 55106-9

Active ingredient:

  • Zinc Pyrithione 1%
  • Salicylic Acid 2%

Section 60561-8

Other information:

  • store at 20°C to 25°C (68°F-77°F)
  • see top panel for lot number and expiration date
Package


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Controls dandruff, flaking, and itching
  • Helps relieve symptoms of seborrheic dermatitis
  • Clears scalp buildup and supports healthy scalp environment
Dosage and Administration (34068-7)

Directions:

  • Shake well before use
  • Apply to wet scalp
  • Gently massage and leave on for 3-5 minutes
  • Rinse thoroughly
  • Use 2-3 times weekly, or as directed by your dermatologist
Warnings and Precautions (34071-1)

For external use only

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

Section 50567-7 (50567-7)

When using this product

• Avoid contact with eyes. If contact occurs, rinse thoroughly.

Section 50569-3 (50569-3)

Ask a doctor before use if you have:

• Sensitive skin

Section 50570-1 (50570-1)

On broken or irritated skin.

Section 51727-6 (51727-6)

Inactive ingredients:

  • Salicylic Acid
  • Zinc Pyrithione
  • Stemona Tuberosa Root
  • Bassia Scoparia Fruit
  • Zingiber Officinale Whole
  • Platycladus Orientalis Leaf
  • Sauromatum Giganteum Whole
  • Reynoutria Multiflora Root
  • Mentha Canadensis Whole
  • Dryobalanops Aromatica Resin
  • Gleditsia Sinensis Fruit
  • Cnidium Monnieri Fruit

Section 53413-1 (53413-1)

Questions or comments?

Contact us at [email protected]

Section 53414-9 (53414-9)

If pregnant or breast-feeding

• Ask a health professional before use

Section 55105-1 (55105-1)

  • Purpose 1: Anti-Dandruff ( Active ingredient:Zinc Pyrithione 1% )
  • Purpose 2: Anti-seborrheic dermatitis ( Active ingredient:Salicylic Acid 2% )
Section 55106-9 (55106-9)

Active ingredient:

  • Zinc Pyrithione 1%
  • Salicylic Acid 2%

Section 60561-8 (60561-8)

Other information:

  • store at 20°C to 25°C (68°F-77°F)
  • see top panel for lot number and expiration date
Package (package)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)