BIOKERA - pyrithione zinc lotion/shampoo 
SALERM COSMETICA PROFESIONAL, S.A.

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

Inactive Ingredients: Water, Sodium Laureth Sulfate,

Cocomidopropyl Betane, Acrylates Copolymenr, Frangrance,

Linum Usitatissimum (Linseed) Seed Oil, Salicylic Acid,

Polyquaternum 7, Laureth 4, Glycol Distearate, Cocamide

Mipa, Undecylenamidopropyltrimonium Methosulfate,

Propylene Glycol, Sodium Hydroxide, Sodium Chloride,

Diazolidinyl Urea, Methylsothiazolinine, Iodopropynol

Butylcarbamate, Lactic Acid, Alpha Isomethylionine,

Citronellol

Active Ingredient

Pyrithione Zinc 1,0 %

Purpose

Anti-dandruff

Keep this and all drugs out of

reach of children.

If swallowed, get medical help or contact a Poison Control

Center right away

Uses helps 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

Directions

-For the best results use at least twice a week or as directed

by a doctor.

-Wet the hair with warm water and apply the shampoo

evenly throughout the first wash. Rinse and apply

again. Leave in for a few minutes and rinse again,

Questions or comments?

www.salerm.com -  0034 93 860 81 11

copy of label

BIOKERA  
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59538-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CHLOROPROPYLATE (UNII: GI03ROM7HQ)  
LINSEED OIL (UNII: 84XB4DV00W)  
HEXYL SALICYLATE (UNII: 8F78EY72YL)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
LAURETH-4 (UNII: 6HQ855798J)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
3-IODO-1-PROPANOL (UNII: 2FR2742AOL)  
LACTIC ACID (UNII: 33X04XA5AT)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59538-001-011 in 1 CARTON08/01/2013
1300 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/01/2013
Labeler - SALERM COSMETICA PROFESIONAL, S.A. (563418532)

Revised: 7/2016
Document Id: 2d2779a3-d793-4635-8509-44e775a916dd
Set id: a6c8fef0-c872-45db-a6f4-9f628bcdffc2
Version: 4
Effective Time: 20160702
 
SALERM COSMETICA PROFESIONAL, S.A.