ANTIDANDRUFFSHAMPOO- pyrithione zinc shampoo shampoo

AntiDandruffShampoo by

Drug Labeling and Warnings

AntiDandruffShampoo by is a Otc medication manufactured, distributed, or labeled by Peer Pharm Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Zinc Pyrithione 1.0%

Controls Dandruff

Keep out of reach of children.

Controls itching and flaking associated with dandruff

For external use only. Avoid contact with eyes. If contact occurs, rinse eyes throughly with water. If condition worsens or does not improve after regular use of this product as directed, consult a doctor.

Wet hair, apply shampoo and work into a lather. Rinse thoroughly with warm water. For best results, use at least twice a week or as direct by a doctor.

INGREDIENTS AND APPEARANCE

ANTIDANDRUFFSHAMPOO 
pyrithione zinc shampoo shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1608
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
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURETH-12 SULFATE (UNII: E1ZP93931S)
GLYCERIN (UNII: PDC6A3C0OX)
JOJOBA OIL (UNII: 724GKU717M)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
ACRYLAMIDOPROPYLTRIMONIUM CHLORIDE/ACRYLAMIDE COPOLYMER (400 MPA.S) (UNII: 2RX4MI2LCX)
SHEANUT OIL (UNII: O88E196QRF)
LACTIC ACID (UNII: 33X04XA5AT)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM BENZOATE (UNII: OJ245FE5EU)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
ARGAN OIL (UNII: 4V59G5UW9X)
CARBOMER 1342 (UNII: 809Y72KV36)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1608-1	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	03/23/2016

Labeler - Peer Pharm Ltd. (514678390)

Registrant - Peer Pharm Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharm Ltd.		514678390	manufacture(69435-1608)