9a9b1fa8-7681-4d4a-8c46-4f3488dd614d

SPL v1
SPL
SPL Set ID 9a9b1fa8-7681-4d4a-8c46-4f3488dd614d
Route
topical
Published
Effective Date 2022-11-02
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 2022-11-01

Purpose

Seborrheic dermatitis

Description

Pyrithione Zinc


Medication Information

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.

Uses

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

• Helps eliminate recurrence of seborrheic dermatitis

Purpose

Seborrheic dermatitis

Directions

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

Other Information

• Store at 59° to 77°F (15° to 25°C)

Inactive Ingredients

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

Description

Pyrithione Zinc

Section 50565-1

Product Label

Active Ingredient

Pyrithione Zinc

Questions Or Comments

Structured Label Content

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.

Uses

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

• Helps eliminate recurrence of seborrheic dermatitis

Purpose

Seborrheic dermatitis

Directions

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

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

Section 50565-1 (50565-1)

Product Label (Product label)

Active Ingredient

Pyrithione Zinc

Questions Or Comments (Questions or Comments)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)