2IN1 DANDRUFF AND CONDITIONER- pyrithione zinc shampoo 
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil

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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DRUG FACTS

Active Ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

• helps to treat flakes, itch, irritation, oilness or dryness caused by dandruff.

Warnings

For external use only

When using this product

 •avoid contact with eyes • if contact occurs, rinse eyes with plenty of water.

Stop use and ask a doctor if

condition does not improve or worsen after regular use of this product as directed

Keep this and all drugs out of reach of children

If swallowed get medical help or contact a Poison Control Center right away.

Directions

•wet hair, •squeeze small amount into palm •lather, •rinse well

Inactive ingredients

water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, glycol distearate, sodium chloride, acrylates copolymer, dimethicone, zinc sulfate, fragrance, polyquaterinum-10, cetyl alcohol, triethanolamine, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, FDC blue no.1

Package Label

image of package label

2IN1  DANDRUFF AND CONDITIONER
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51357-001
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
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC SULFATE (UNII: 89DS0H96TB)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
TROLAMINE (UNII: 9O3K93S3TK)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51357-001-23700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:51357-001-14420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/15/2012
Labeler - Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil (566220234)
Establishment
NameAddressID/FEIBusiness Operations
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil566220234manufacture(51357-001)

Revised: 7/2012
Document Id: a618218f-7901-4603-b73d-bc6d459f94cb
Set id: 8a625853-4ec6-489a-ada0-fa3dd3840bb1
Version: 1
Effective Time: 20120716
 
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil