83037-001-08

83037-001-08
SPL v2
SPL
SPL Set ID 05e3fac4-c0ce-cbb9-e063-6294a90ac036
Route
TOPICAL
Published
Effective Date 2023-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (1 g)
Inactive Ingredients
Coco Monoethanolamide .alpha.-hexylcinnamaldehyde Anhydrous Citric Acid Sodium Hydroxide Water Sodium C14-16 Olefin Sulfonate Cocamidopropylamine Oxide Phenoxyethanol Fd&c Blue No. 1 Linalool, (+)- Benzyl Salicylate Coumarin Panthenol Geraniol Cocamidopropyl Betaine Caprylyl Glycol Edetate Disodium Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600 Kd) Isomethyl-.alpha.-ionone Hexylene Glycol

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-22

Description

Zinc Pyrithione 1%


Medication Information

Warnings and Precautions

For external use only.

Do not use on wounds or damaged skin or on a child under 12 years of age unless directed by a physician.

Indications and Usage

For the relief of the symptoms of dandruff.

Dosage and Administration

Apply a small amount quantity of the product into hair and massage the scalp.

Rinse thoroughly with enough water, repeat if needed.

For best results, use at least twice a week or as directed by a doctor.

Description

Zinc Pyrithione 1%

Section 50565-1

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

Section 50566-9

Conditions worsens or does not improve after regular use of this product as directed.

Section 50567-7

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Section 51727-6

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Acrylates Copolymer, Cocamide MEA, Cocamidopropylamine Oxide, Caprylyl Glycol, Hexylene Glycol, Fragrance (Parfum), Polyquaternium-7, Sodium Hydroxide, Disodium EDTA, Citric Acid, Panthenol, Phenoxyethanol, FD&C Blue No.1 (CI 42090), Hexyl Cinnamal, Benzyl Salicylate, Coumarin, Alpha-Isomethyl Ionone, Geraniol, Linalool.

Section 53413-1

QUESTION OR COMMENTS?

Call (305)-900-8256

Section 55105-1

Anti-Dandruff

Section 55106-9

Zinc Pyrithione 1%

Section 60561-8

See on the bottom of the bottle for lot number and expiration date.

Dzul Anti Dandruff Shampoo


Structured Label Content

Indications and Usage (34067-9)

For the relief of the symptoms of dandruff.

Dosage and Administration (34068-7)

Apply a small amount quantity of the product into hair and massage the scalp.

Rinse thoroughly with enough water, repeat if needed.

For best results, use at least twice a week or as directed by a doctor.

Warnings and Precautions (34071-1)

For external use only.

Do not use on wounds or damaged skin or on a child under 12 years of age unless directed by a physician.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Conditions worsens or does not improve after regular use of this product as directed.

Section 50567-7 (50567-7)

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Section 51727-6 (51727-6)

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Acrylates Copolymer, Cocamide MEA, Cocamidopropylamine Oxide, Caprylyl Glycol, Hexylene Glycol, Fragrance (Parfum), Polyquaternium-7, Sodium Hydroxide, Disodium EDTA, Citric Acid, Panthenol, Phenoxyethanol, FD&C Blue No.1 (CI 42090), Hexyl Cinnamal, Benzyl Salicylate, Coumarin, Alpha-Isomethyl Ionone, Geraniol, Linalool.

Section 53413-1 (53413-1)

QUESTION OR COMMENTS?

Call (305)-900-8256

Section 55105-1 (55105-1)

Anti-Dandruff

Section 55106-9 (55106-9)

Zinc Pyrithione 1%

Section 60561-8 (60561-8)

See on the bottom of the bottle for lot number and expiration date.

Dzul Anti Dandruff Shampoo (DZUL ANTI-DANDRUFF SHAMPOO)


Advanced Ingredient Data


Raw Label Data

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