ANTIDANDRUFFSHAMPOO- pyrithione zinc shampoo shampoo 
Peer Pharm Ltd.

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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Arganicare Anti-Dandruff Shampoo

Arganicare PDP

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.

ANTIDANDRUFFSHAMPOO 
pyrithione zinc shampoo shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1608
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69435-1608-1400 mL in 1 BOTTLE; Type 0: Not a Combination Product03/23/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H03/23/2016
Labeler - Peer Pharm Ltd. (514678390)
Registrant - Peer Pharm Ltd. (514678390)
Establishment
NameAddressID/FEIBusiness Operations
Peer Pharm Ltd.514678390manufacture(69435-1608)

Revised: 6/2016
Document Id: 35c88007-95d8-7283-e054-00144ff8d46c
Set id: 2eb93d7c-333d-4b93-e054-00144ff88e88
Version: 5
Effective Time: 20160621
 
Peer Pharm Ltd.