SPL v1
SPL
SPL Set ID b9b5ab01-81c2-4832-9bd8-9001258cfc2a
Route
TOPICAL
Published
Effective Date 2022-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (0.1 g)
Inactive Ingredients
Water Propylene Glycol Panthenol Minoxidil Green Tea Leaf Biotin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-09-01

Description

Pyrithione Zinc

Purpose

Seborrheic dermatitis


Medication Information

Purpose

Seborrheic dermatitis

Description

Pyrithione Zinc

Uses

•Relieves scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis.

• Helps eliminate recurrence of seborrheic dermatitis

Section 50565-1

Warnings

For external use only

Ask a doctor before use if condition covers a large area.

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

Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed.

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

Directions

Apply to affected area one ml two times daily or as directed by the physician

Product Label

Active Ingredient

Pyrithione Zinc

Other Information

• Store at 59° to 77°F (15° to 25°C)

Inactive Ingredients

Purified Water, Propylene Glycol, Vitamin B5, Minoxidil, Green Tea, Biotin


Structured Label Content

Uses

•Relieves scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis.

• Helps eliminate recurrence of seborrheic dermatitis

Section 50565-1 (50565-1)

Purpose

Seborrheic dermatitis

Warnings

For external use only

Ask a doctor before use if condition covers a large area.

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

Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed.

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

Directions

Apply to affected area one ml two times daily or as directed by the physician

Product Label

Active Ingredient

Pyrithione Zinc

Other Information (Other information)

• Store at 59° to 77°F (15° to 25°C)

Inactive Ingredients (Inactive ingredients)

Purified Water, Propylene Glycol, Vitamin B5, Minoxidil, Green Tea, Biotin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)