80465-001-10

PYRITHIONE ZINC- pyrithione zinc shampoo
EROS GLOBAL CORP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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80465-001-10

For maximum dandruff control, use every time you shampoo.
Wet hair, massage unto scalp, rinse, and repeat if desired.

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

For external use only. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Aqua, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Cocoamide DEA, Acrylates/Steareth-20 Methacrylate Copolymer, Propylene Glycol, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Methylparaben, Propylparaben, Parfum, Polyquaternium-7, Phosphoric Acid, FD&C Blue 1/ CI 42090, Limonene.

Anti-Dandruff Shampoo Helps prevent recurrence of flaking and itching associated with dandruff.

Keep Out of children’s reach.

Anti-dandruff

Pyrithione Zinc 1%

10 OZ

PYRITHIONE ZINC
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80465-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PHOSPHORIC ACID (UNII: E4GA8884NN)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
BASIC BLUE 1 (UNII: 92N74OA24D)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80465-001-10	283 g in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M032	09/21/2020

Labeler - EROS GLOBAL CORP (117597821)

Registrant - CHEMCO CORPORATION (032495954)

Name	Address	ID/FEI	Business Operations
Establishment
CHEMCO CORPORATION		032495954	manufacture(80465-001)