Zinc Pyrithione by Harry's Inc. ZINC PYRITHIONE shampoo

Zinc Pyrithione by

Drug Labeling and Warnings

Zinc Pyrithione by is a Otc medication manufactured, distributed, or labeled by Harry's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

for relief and to help prevent recurrence of
flaking and itching associated with dandruff.

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

for best results use at least twice a week or as
directed by a doctor.
shake before use.
wet hair, massage onto scalp, rinse, repeat if desired.

Inactive ingredients

Water/Aqua/Eau, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Lauric Acid, Disodium Cocoamphodiacetate, Decyl Glucoside, Polysorbate 20, Sodium Chloride, Citric Acid, Acrylates Copolymer, Glycerin, Phenoxyethanol, Polyquaternium-6, Coconut Acid, Mentha Piperita (Peppermint) Oil, PEG-120 Methyl Glucose Dioleate, Polyquaternium-67, Coco-Glucoside, Glyceryl Oleate, Eucalyptus Globulus Leaf Oil, Guar Hydroxypropyltrimonium Chloride, Menthol, Butylene Glycol, Lavandula Hybrida Oil, Carica Papaya (Papaya) Fruit Extract, Chlorphenesin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Raphanus Sativus (Radish)
Root Extract, Potassium Hydroxide , Sodium Lauroyl Lactylate, Lavandula Angustifolia (Lavender) Oil, Sodium Caproyl Lactylate,
Propylene Glycol, Ferula Galbaniflua (Galbanum) Resin Oil, Sodium Polynaphthalenesulfonate, Sodium Acetate, Piper Nigrum (Pepper) Fruit Extract, Xanthan Gum, Isopropyl Alcohol, Benzoic Acid, Dehydroacetic Acid, Inga Alba Bark Extract, Tocopherol, Hydrogenated Palm Glycerides, Lecithin, Ascorbyl Palmitate, Linalool, Limonene.

QUESTIONS

Questions? 1-888-212-6855

PRINCIPAL DISPLAY PANEL

414ml NDC: 70533-003-14

59ml NDC: 70533-003-02

INGREDIENTS AND APPEARANCE

ZINC PYRITHIONE 
zinc pyrithione shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70533-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
POLYQUATERNIUM-6 (15000 MW) (UNII: YFL33X52PX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)
ALOE (UNII: V5VD430YW9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PAPAYA (UNII: KU94FIY6JB)
LAURIC ACID (UNII: 1160N9NU9U)
INGA ALBA BARK (UNII: 942K688993)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LAVANDIN OIL (UNII: 9RES347CKG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCO GLUCOSIDE (UNII: ICS790225B)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
RACEMENTHOL (UNII: YS08XHA860)
CHLORPHENESIN (UNII: I670DAL4SZ)
TEA TREE OIL (UNII: VIF565UC2G)
GALBANUM OIL (UNII: 211UF7M8N1)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
GLYCERYL OLEATE (UNII: 4PC054V79P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0)
WHITE PEPPER (UNII: M29DW54Q9E)
RAPHANUS SATIVUS VAR. CAUDATUS ROOT (UNII: 1D6EC6L1NP)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
COCONUT ACID (UNII: 40U37V505D)
PEPPERMINT OIL (UNII: AV092KU4JH)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SODIUM CAPROYL LACTYLATE (UNII: 87WR3BHC09)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70533-003-14	414 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020	10/01/2026
2	NDC: 70533-003-02	59 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2020	10/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	10/01/2020	10/01/2026

Labeler - Harry's Inc. (079239206)