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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: 59538-003

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, Alcohol Denat., Linum Usitatissium,

(Linseed) Seed Oil, Cetrimonium Chloride, Peg-40 Hydrogenated

Castor Oil, Disodium Edta, Sodium Hydroxide, Fragrance

Active Ingredient

Pyrithione Zinc 0,1 %

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

-Apply to affected areas one to four time daily or as directed by a doctor.

-Firstly, wash the hair with anti-dandruff shampoo. Shake the phial well

before use and then evenly apply the contents to the scalp.

Gently massage in with the fingertips using an outward and inward motion

or allow to absorb and, without rinsing, style the hair in the usual manner.

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:59538-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC.1 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
FLAX SEED 
LINSEED OIL 
CETRIMONIUM CHLORIDE 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
EDETATE DISODIUM 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:59538-003-036 VIAL in 1 CARTON
160 g in 1 VIAL
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: 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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