Dermazinc Spray/drop

Dermazinc Spray/drop
SPL v4
SPL
SPL Set ID e73010ae-291d-6adf-e053-2a95a90a8aea
Route
TOPICAL
Published
Effective Date 2022-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (0.25 g)
Inactive Ingredients
Isopropyl Myristate Undecylenic Acid Sodium Lauryl Sulfate Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-29

Description

Pyrithione Zinc 0.25%


Medication Information

Warnings and Precautions

Warnings

■ For external use only.

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

When using this product avoid contact with the 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 this

product as directed.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

For relief of the symptoms of seborrheic dermatitis and dandruff.

Dosage and Administration



Apply to affected areas twice daily or as directed by a doctor.

Description

Pyrithione Zinc 0.25%

Section 50565-1

Keep Out of Reach of Children.

Section 51727-6

Isopropyl Myristate, SD-Alcohol 40-B, Sodium Lauryl Sulfate, Undecylinic Acid

Section 51945-4

Section 55105-1

Anti-dandruff

Seborrheic Dermatitis treatment

Section 55106-9

Pyrithione Zinc 0.25%

Inner/immediate Label


Structured Label Content

Indications and Usage (34067-9)

For relief of the symptoms of seborrheic dermatitis and dandruff.

Dosage and Administration (34068-7)



Apply to affected areas twice daily or as directed by a doctor.

Warnings and Precautions (34071-1)

Warnings

■ For external use only.

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

When using this product avoid contact with the 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 this

product as directed.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep Out of Reach of Children.

Section 51727-6 (51727-6)

Isopropyl Myristate, SD-Alcohol 40-B, Sodium Lauryl Sulfate, Undecylinic Acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-dandruff

Seborrheic Dermatitis treatment

Section 55106-9 (55106-9)

Pyrithione Zinc 0.25%

Inner/immediate Label (Inner/Immediate Label)


Advanced Ingredient Data


Raw Label Data

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