Balancing Shampoo (73528-100)

Balancing Shampoo (73528-100)
SPL v8
SPL
SPL Set ID 984780fd-4969-150b-e053-2995a90aed77
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (1 g)
Inactive Ingredients
Water Leuconostoc/radish Root Ferment Filtrate Arginine Illicium Verum Whole Xanthan Gum Hydroxyethylcellulose Pisum Sativum Whole 1,2-hexanediol Pentylene Glycol Polyquaternium-73 Punica Granatum Fruit Juice Cocamidopropyl Hydroxysultaine Lactobacillus Camellia Sinensis Leaf Oil Linalool Vanillin Glycolic Acid Squalane Ethylhexylglycerin Gluconolactone Sodium Benzoate Menthol 3-octanone Sodium Mono- And Dimethyl Naphthalene Sulfonates Lavandin Oil Ethyl Acrylate And Methyl Methacrylate Copolymer (2:1; 750000 Mw) Butylene Glycol Panthenol Citrus Limon (lemon) Peel Oil Pentadecalactone Caprylyl Glycol Octenidine Hcl Camphor, (-)- Terpineol Glycerin Raphanus Sativus Var. Caudatus Root Geraniol 3-hexenol Rosmarinus Officinalis (rosemary) Leaf Oil Caprylic/capric Triglyceride Yeast, Unspecified Pyrus Malus (apple) Juice Potassium Hydroxide Allium Sativum (garlic) Bulb Oil Saccharina Latissima Linalyl Acetate Hexyl Acetate Sodium C14-16 Olefin Sulfonate Sodium Chloride Citric Acid Lavandula Angustifolia (lavender) Oil Limonene, (+/-)- Mentha Piperita (peppermint) Oil Dipropylene Glycol Potassium Sorbate Propylene Glycol Salvia Officinalis (sage) Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-01
Description

Zinc Pyrithione 1.0%

Purpose

Anti-Dandruff, Anti-seborrheic dermatitis

Medication Information

Warnings and Precautions

For external use only

Purpose

Anti-Dandruff, Anti-seborrheic dermatitis

Description

Zinc Pyrithione 1.0%

Uses

For the relief of symptoms from scalp itch, irritation, flaking and redness associated with dandruff.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Section 50567-7

When using this product avoid contact with eyes. If contact offurs rinse eyes thoroughly with water.

Section 51945-4

Questions

1-877-No-Flake (1-877-663-5253)

Directions
  • Wet hair, massage shampoo onto scalp
  • Rinse off and repeat if desired
  • For best results, use at least twice a week or as directed by a doctor
Active Ingredient

Zinc Pyrithione 1.0%

Inactive Ingredients

Aqua (Water, Eau), Sodium Cocoyl Isethionate, Sodium Lauroamphoacetate, Acrylates Copolymer, Ethylhexyl Olivate, Stearyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil, Allium Sativum (Garlic) Bulb Extract, Pyrus Malus (Apple) Fruit Extract, Camellia Sinensis Leaf Extract, Panthenol, Citrus Nobilis (Mandarin Orange) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Lavandula Angustifolia (Lavender) Oil, Mentha Citrata Oil, Orbignya Oleifera Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Salvia Sclarea (Clary) Oil, Vanillin, Cocos Nucifera (Coconut) Oil, Laminaria Saccharina Extract, Squalane, Caprylyl Glycol, Yeast Ferment Extract, Guar Hydroxypropyltrimonium Chloride, Glycerin, Sodium Isethionate, Lactobacillus Ferment, Octenidine HCl, Sodium Polynaphthalenesulfonate, Xanthan Gum, Hexamidine Diisethionate, Ethylhexylglycerin, Coconut Alcohol, Raphanus Sativus (Radish) Root Extract, Arginine, Glycolic Acid, Polyquaternium-73, Pentylene Glycol, Propylene Glycol, Sodium Chloride, Potassium Sorbate, Sodium Benzoate, Citric Acid, Linalool

Structured Label Content

Uses

For the relief of symptoms from scalp itch, irritation, flaking and redness associated with dandruff.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact offurs rinse eyes thoroughly with water.

Section 51945-4 (51945-4)

Purpose

Anti-Dandruff, Anti-seborrheic dermatitis

Questions

1-877-No-Flake (1-877-663-5253)

Directions
  • Wet hair, massage shampoo onto scalp
  • Rinse off and repeat if desired
  • For best results, use at least twice a week or as directed by a doctor
Active Ingredient

Zinc Pyrithione 1.0%

Inactive Ingredients

Aqua (Water, Eau), Sodium Cocoyl Isethionate, Sodium Lauroamphoacetate, Acrylates Copolymer, Ethylhexyl Olivate, Stearyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil, Allium Sativum (Garlic) Bulb Extract, Pyrus Malus (Apple) Fruit Extract, Camellia Sinensis Leaf Extract, Panthenol, Citrus Nobilis (Mandarin Orange) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Lavandula Angustifolia (Lavender) Oil, Mentha Citrata Oil, Orbignya Oleifera Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Salvia Sclarea (Clary) Oil, Vanillin, Cocos Nucifera (Coconut) Oil, Laminaria Saccharina Extract, Squalane, Caprylyl Glycol, Yeast Ferment Extract, Guar Hydroxypropyltrimonium Chloride, Glycerin, Sodium Isethionate, Lactobacillus Ferment, Octenidine HCl, Sodium Polynaphthalenesulfonate, Xanthan Gum, Hexamidine Diisethionate, Ethylhexylglycerin, Coconut Alcohol, Raphanus Sativus (Radish) Root Extract, Arginine, Glycolic Acid, Polyquaternium-73, Pentylene Glycol, Propylene Glycol, Sodium Chloride, Potassium Sorbate, Sodium Benzoate, Citric Acid, Linalool

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:25.765400 · Updated: 2026-03-14T23:13:03.799451