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, Alcohol Denat., Linum Usitatissium,

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

Castor Oil, Disodium Edta, Sodium Hydroxide, Fragrance

ACTIVE INGREDIENT

Active Ingredient

Pyrithione Zinc 0,1 %

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

-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

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: 59538-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	.1 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
FLAX SEED (UNII: 4110YT348C)
LINSEED OIL (UNII: 84XB4DV00W)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59538-003-03	6 in 1 CARTON	08/01/2013
1		60 g in 1 VIAL; 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)