BIOKERA- pyrithione zinc lotion/shampoo

biokera by

Drug Labeling and Warnings

biokera by is a Otc medication manufactured, distributed, or labeled by SALERM COSMETICA PROFESIONAL, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

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

Active Ingredient

Pyrithione Zinc 0,5 %

PURPOSE

Purpose

Anti-dandruff

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of

reach of children.

If swallowed, get medical help or contact a Poison Control

Center right away

INDICATIONS & USAGE

Uses helps prevent recurrence of flaking and itching

associated with dandruff

WARNINGS

Warnings

For external use only

WHEN USING

When using this product

-avoid contact with eyes. If contact occurs, rinse eyes

thoroughly with water

STOP USE

Stop use and ask a doctor if

-condition worsens or does not improve after regular use

of this product as directed

DOSAGE & ADMINISTRATION

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

Questions or comments?

www.salerm.com -  0034 93 860 81 11

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOKERA  
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59538-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	.5 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59538-002-02	1 in 1 CARTON	08/01/2013
1		196 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	08/01/2013

Labeler - SALERM COSMETICA PROFESIONAL, S.A. (563418532)