Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d3a185a0-3010-4fe3-a113-ddd7cd46d542
Route
TOPICAL
Published
Effective Date 2015-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (1.05 g)
Inactive Ingredients
Water Biotin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-07-20
Description

zinc pyrithione

Medication Information

Warnings and Precautions

1. Do not use in the following cases(Eczema and scalp wounds)

2.Side Effects

1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor

3.General Precautions

1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately

2)This product is for exeternal use only. Do not use for internal use

4.Storage and handling precautions

1)If possible, avoid direct sunlight and store in cool and area of low humidity

2)In order to maintain the quality of the product and avoid misuse

3)Avoid placing the product near fire and store out in reach of children



Indications and Usage

-Moisten hair and scalp with warm water sufficiently and massage the scalp with 3~5ml. -Apply a proper amount to foam and apply to the hair and scalp sufficiently. -Massage for about 3 minutes and rinse.

Dosage and Administration

for external use only



Description

zinc pyrithione

Section 50565-1

keep out or reach of the children



Section 51727-6

water, nicotinamide, d-panthenol, biotin, l-menthol, etc.



Section 51945-4
Section 55105-1

scalp protectant



Section 55106-9

zinc pyrithione



Structured Label Content

Indications and Usage (34067-9)

-Moisten hair and scalp with warm water sufficiently and massage the scalp with 3~5ml. -Apply a proper amount to foam and apply to the hair and scalp sufficiently. -Massage for about 3 minutes and rinse.

Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)

1. Do not use in the following cases(Eczema and scalp wounds)

2.Side Effects

1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor

3.General Precautions

1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately

2)This product is for exeternal use only. Do not use for internal use

4.Storage and handling precautions

1)If possible, avoid direct sunlight and store in cool and area of low humidity

2)In order to maintain the quality of the product and avoid misuse

3)Avoid placing the product near fire and store out in reach of children



Section 50565-1 (50565-1)

keep out or reach of the children



Section 51727-6 (51727-6)

water, nicotinamide, d-panthenol, biotin, l-menthol, etc.



Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

scalp protectant



Section 55106-9 (55106-9)

zinc pyrithione



Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:58.024259 · Updated: 2026-03-14T22:54:03.234260