Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 8d8a6908-caae-65b5-e053-2995a90a1bb6
Route
TOPICAL
Published
Effective Date 2019-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.2 g) Pyrithione Zinc (0.3 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-07-13

Description

zinc pyrithione, salicylic acid


Medication Information

Warnings and Precautions

1. In case of using cosmetics or after use, please consult a specialist if there is any abnormal symptom or side effect such as red spot, swelling or itching in direct sunlight.

2. Do not use on wounded areas.

3. In case of contact with eyes, wash immediately.

4. Care should be taken not to rinse with water after use, as it may cause hair loss or discoloration.

Indications and Usage

1. APPLY TO WET HAIR WITH WARM WATER AND MASSAGE SCALP GENTLY.

2. WAIT 3 MINUTES THEN RINSE OFF (3. USE ACTIVATOR AFTER DRYING HAIR)

Dosage and Administration

for topical use only

Description

zinc pyrithione, salicylic acid

Section 50565-1

keep out of reach of the children

Section 51727-6

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide MIPA, Isopropanolamine, Zinc Pyrithione, Sodium Polynaphthalenesulfonate, Panthenol, Pantolactone, Menthol, Isopulegol, Polyquaternium-10, Pinus Sylvestris Leaf Extract, Pentylene Glycol, Caprylyl Glycol, Butylene Glycol, Eucalyptus Globulus Leaf Oil, Mentha Arvensis Leaf Oil, Amyris Balsamifera Bark Oil, Eucalyptus Globulus Leaf Oil, Litsea Cubeba Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Salicylic Acid, Chlorphenesin, Citric Acid, Disodium EDTA, Artemisia Vulgaris Extract, Curcuma Longa (Turmeric) Root Extract, Angelica Gigas Root Extract, Astragalus Membranaceus Root Extract, Acorus Gramineus Root/Stem Extract, Ginkgo Biloba Leaf Extract, Morus Bombycis Leaf Extract, Panax Ginseng Root Extract, 1,2-Hexanediol, Glycerin, Copper Tripeptide-1, Rehmannia Glutinosa Root Extract, Cornus Officinalis Fruit Extract, Dioscorea Japonica Root Extract, Alisma Orientale Tuber Extract, Poria Cocos Sclerotium Extract, Paeonia Suffruticosa Root Extract, Ethylhexylglycerin

Section 51945-4

Section 55105-1

Protect scalp, hair loss prevention

Section 55106-9

zinc pyrithione, salicylic acid


Structured Label Content

Indications and Usage (34067-9)

1. APPLY TO WET HAIR WITH WARM WATER AND MASSAGE SCALP GENTLY.

2. WAIT 3 MINUTES THEN RINSE OFF (3. USE ACTIVATOR AFTER DRYING HAIR)

Dosage and Administration (34068-7)

for topical use only

Warnings and Precautions (34071-1)

1. In case of using cosmetics or after use, please consult a specialist if there is any abnormal symptom or side effect such as red spot, swelling or itching in direct sunlight.

2. Do not use on wounded areas.

3. In case of contact with eyes, wash immediately.

4. Care should be taken not to rinse with water after use, as it may cause hair loss or discoloration.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide MIPA, Isopropanolamine, Zinc Pyrithione, Sodium Polynaphthalenesulfonate, Panthenol, Pantolactone, Menthol, Isopulegol, Polyquaternium-10, Pinus Sylvestris Leaf Extract, Pentylene Glycol, Caprylyl Glycol, Butylene Glycol, Eucalyptus Globulus Leaf Oil, Mentha Arvensis Leaf Oil, Amyris Balsamifera Bark Oil, Eucalyptus Globulus Leaf Oil, Litsea Cubeba Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Salicylic Acid, Chlorphenesin, Citric Acid, Disodium EDTA, Artemisia Vulgaris Extract, Curcuma Longa (Turmeric) Root Extract, Angelica Gigas Root Extract, Astragalus Membranaceus Root Extract, Acorus Gramineus Root/Stem Extract, Ginkgo Biloba Leaf Extract, Morus Bombycis Leaf Extract, Panax Ginseng Root Extract, 1,2-Hexanediol, Glycerin, Copper Tripeptide-1, Rehmannia Glutinosa Root Extract, Cornus Officinalis Fruit Extract, Dioscorea Japonica Root Extract, Alisma Orientale Tuber Extract, Poria Cocos Sclerotium Extract, Paeonia Suffruticosa Root Extract, Ethylhexylglycerin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Protect scalp, hair loss prevention

Section 55106-9 (55106-9)

zinc pyrithione, salicylic acid


Advanced Ingredient Data


Raw Label Data

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