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biokera by SALERM COSMETICA PROFESIONAL, S.A.

Dosage form: lotion/shampoo
Ingredients: PYRITHIONE ZINC 1g in 10g
Labeler: SALERM COSMETICA PROFESIONAL, S.A.
NDC Code: 59538-004

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.

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

BIOKERA  
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59538-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC1 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH-3 SULFATE 
COCAMIDOPROPYL BETAINE 
CHLOROPROPYLATE 
LINSEED OIL 
HEXYL SALICYLATE 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) 
LAURETH-4 
GLYCOL DISTEARATE 
COCO MONOISOPROPANOLAMIDE 
PROPYLENE GLYCOL 
SODIUM HYDROXIDE 
SODIUM CHLORIDE 
DIAZOLIDINYL UREA 
METHYLISOTHIAZOLINONE 
3-IODO-1-PROPANOL 
LACTIC ACID 
ISOMETHYL-.ALPHA.-IONONE 
.BETA.-CITRONELLOL, (R)- 
Packaging
#Item CodePackage Description
1NDC:59538-004-011 BOTTLE in 1 CARTON
11020 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/01/2013
Labeler - SALERM COSMETICA PROFESIONAL, S.A. (563418532)

Revised: 07/2016
 
SALERM COSMETICA PROFESIONAL, S.A.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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