BALANCING- pyrithione zinc shampoo

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient

• Active Ingredient: Purpose
• Pyrithione Zinc 1%: Anti-Dandruff, Anti-Seborrhic Dermatitis

Uses

Uses

For relief, and to help prevent reoccurance, of flaking and itching associated with dandruff and seborrhic dermatitis

WARNINGS

Warnings

For external use only

When using this product avoid contact with 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

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

Directions

Wet hair, massage shampoo onto scalp. Rinse off after 2-3 minutes and repeat if desired. For best results, use at least twice a week or as directed by a doctor

INACTIVE INGREDIENT

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Hydroxysultaine, Glycerin, Acrylates Copolymer, Glycolic Acid, Pisum Sativum (Pea) Peptide, Gluconolactone, Hydroxyethylcellulose, Sodium Chloride, Butylene Glycol, Sodium Benzoate, Potassium Sorbate, Squalane, Caprylic/Capric Triglyceride, Propylene Glycol, Raphanus Sativus (Radish) Root Extract, Punica Granatum Extract, Yeast Ferment Filtrate, Panthenol, Pyrus Malus (Apple) Fruit Extract, Potassium Hydroxide, Rosmarinus Officinalis (Rosemary) Leaf Extract, Leuconostoc/Radish Root Ferment Filtreate, Sodium Polynaphthalenesulfonate, Lactobacillus Ferment, Camellia Sinensis Leaf Extract, Allium Sativum (Garlic) Bulb Extract, Xanthan Gum, 1,2-Hexanediol, Caprylyl Glycol, Leuconostoc Ferment Filtrate, Pentylene Glycol, Ethylhexylglycerin, Laminaria Saccharina Extract, Citric Acid, Polyquaternium-73, Arginine, Octenidine HCl, Camphor, Citrus Limon (Lemon) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Limonene, Linalyl Acetate, Linalool, Mentha Piperita (Peppermint) Oil, Menthol, Terpineol, Vanillin, Lavandin Abrialis Oil, Illicium Verum Oil, Dipropylene Glycol, Pentadecalactone, Geraniol, Hexyl Acetate, Ethyl Amyl Ketone, Salvia Officnialis (Sage) Oil, 3-Hexenol

QUESTIONS

Questions?

1-877-NoFlake (1-877-663-5253)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BALANCING 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73528-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF POWDER (UNII: IJ67X351P9)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MENTHOL (UNII: L7T10EIP3A)
GLYCOLIC ACID (UNII: 0WT12SX38S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LAVANDIN OIL (UNII: 9RES347CKG)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
HEXYL ACETATE (UNII: 7U7KU3MWT0)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
3-OCTANONE (UNII: 79173B4107)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
VANILLIN (UNII: CHI530446X)
ACRYLATES/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
ARGININE (UNII: 94ZLA3W45F)
LINALYL ACETATE (UNII: 5K47SSQ51G)
GERANIOL (UNII: L837108USY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SQUALANE (UNII: GW89575KF9)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CITRUS LIMON (LEMON) PEEL OIL (UNII: I9GRO824LL)
LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)
ILLICIUM VERUM WHOLE (UNII: 52JDS841PX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PYRUS MALUS (APPLE) FRUIT (UNII: B423VGH5S9)
POLYQUATERNIUM-73 (UNII: VRL7GP5AGE)
TERPINEOL (UNII: R53Q4ZWC99)
3-HEXENOL (UNII: V14F8G75P4)
WATER (UNII: 059QF0KO0R)
PISUM SATIVUM WHOLE (UNII: J21YE3W98E)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM NAPHTHALENESULFONATE (UNII: D3F8YRX7TP)
ALLIUM SATIVUM WHOLE (UNII: IIF21WT8O3)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LINALOOL (UNII: D81QY6I88E)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
OCTENIDINE HCL (UNII: U84956NU4B)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTADECALACTONE (UNII: OK17S3S98K)
SALVIA OFFICINALIS (SAGE) OIL (UNII: U27K0H1H2O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
RAPHANUS SATIVUS (UNII: 86R5J6D01D)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73528-110-01	280 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/30/2026
2	NDC: 73528-110-02	85 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/30/2026
3	NDC: 73528-110-03	9 mL in 1 PACKET; Type 0: Not a Combination Product	04/30/2026
4	NDC: 73528-110-04	250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/30/2026
5	NDC: 73528-110-05	415 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/30/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	04/30/2026

Labeler - Zero Flakes Given, Inc. (116933871)