BIOKERA- pyrithione zinc lotion/shampoo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)

Available from:

SALERM COSMETICA PROFESIONAL, S.A.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Anti-dandruff Uses helps prevent recurrence of flaking and itching associated with dandruff Stop use and ask a doctor if -condition worsens or does not improve after regular use of this product as directed

Authorization status:

OTC monograph final

Summary of Product characteristics

BIOKERA - PYRITHIONE ZINC LOTION/SHAMPOO
SALERM COSMETICA PROFESIONAL, S.A.
_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 T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:59 538 -0 0 3
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PYRITHIO NE ZINC (UNII: R9 53O2RHZ5) (PYRITHIONE ZINC - UNII:R9
53O2RHZ5)
PYRITHIONE ZINC
.1 g in 10 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
ALCO HO L (UNII: 3K9 9 58 V9 0 M)
FLAX SEED (UNII: 4110 YT348 C)
SALERM COSMETICA PROFESIONAL, S.A.
LINSEED O IL (UNII: 8 4XB4DV0 0 W)
CETRIMO NIUM CHLO RIDE (UNII: UC9 PE9 5IBP)
PO LYO XYL 4 0 HYDRO GE