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, Propylene Glycol. Cetyl Alcohol,

Glycerin, Cetrimonium Chloride, Cyclopentasiloxane, Linum Usitattisium

(Linseed) Seed oil, Amomethicone,

Polyquaternum 11, Salicylic Acid, Citric Acid,

Diazolidinyl Urea, Disodium Edta, Trideceth 12, Sodium Hydroxide,

Iodopropynyl Butylcarbamate, Fragrance


Active Ingredient

Pyrithione Zinc 0,5 %

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.

-After washing, apply the product to the hair without

touching the scalp. Comb to distribute evenly and leave in to act for a few

minutes. Rinse with warm water and proceed to styling.


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:59538-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC.5 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
LINSEED OIL (UNII: 84XB4DV00W)  
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
HEXYL SALICYLATE (UNII: 8F78EY72YL)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TRIDECETH-12 (UNII: YFY3KG5Y7O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59538-002-021 in 1 CARTON08/01/2013
1196 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: 85d20684-72b9-4650-acba-b24d882f4db7
Set id: b4e50f99-df89-4176-b7ad-d5afb9d2828e
Version: 4
Effective Time: 20160702
 
SALERM COSMETICA PROFESIONAL, S.A.