Biokera lotion/shampoo

Inactive ingredient section

Inactive Ingredients: Water, Alcohol Denat., Linum Usitatissium,

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

Castor Oil, Disodium Edta, Sodium Hydroxide, Fragrance

Otc - active ingredient section

Active Ingredient

Pyrithione Zinc 0,1 %

Otc - purpose section

Purpose

Anti-dandruff

Otc - keep out of reach of children section

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 section

Uses helps prevent recurrence of flaking and itching

associated with dandruff


Warnings section

Warnings

For external use only

Otc - when using section

When using this product

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

thoroughly with water

Otc - stop use section

Stop use and ask a doctor if

-condition worsens or does not improve after regular use

of this product as directed

Dosage & administration section

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.

Otc - questions section

Questions or comments?

www.salerm.com - 0034 93 860 81 11

Ingredients and appearance - Product information

Biokera lotion/shampoo- Pyrithione zinc

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 59538-003
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Pyrithione zinc ( UNII: R953O2RHZ5)( Pyrithione zinc - UNII: R953O2RHZ5 ) .1 gin 10 g

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part358H USA

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

Package label.principal display panel