X FOLATE- zinc pyrithione shampoo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mediceutical Laboratories, LTD

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-dandruff, anti-psoriasis & anti-seborrheic dermatitis. Helps control and prevent flaking & itching associated with dandruff and seborrheic dermatitis.

Authorization status:

OTC monograph final

Summary of Product characteristics

X FOLATE- ZINC PYRITHIONE SHAMPOO
MEDICEUTICAL LABORATORIES, LTD
_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._
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MEDICEUTICAL LABORATORIES - MEDICEUTICALS X-FOLATE (59279-506)
ACTIVE INGREDIENT
1% ZINC PYRITHIONE
PURPOSE
Anti-dandruff, anti-psoriasis & anti-seborrheic dermatitis.
USES
Helps control and prevent flaking & itching associated with dandruff
and seborrheic
dermatitis.
WARNINGS
For external use only. If condition worsens or does not improve after
regular use of this
products as directed, discontinue
and consult a physician. If condition covers large area of the body,
consult your
physician before using this product.
Keep this and all drugs out of the reach of children. If swallowed,
get medical help or
contact a poision control center right away. Avoid contact with eyes.
If contact occurs,
rinse eyes thoroughly with cool water.
DIRECTIONS
For best results use daily or until condition is under control or as
directed by a physician.
For maximum control use every time you shampoo.
1. Apply shampoo to wet hair, massage into hair and scalp, leave on
for 2-3 minutes.
2. Thoroughly rinse and repeat if desired.
3. Apply Therapeutic scalp and hair treatment rinse for 2-3 minutes,
thoroughly rinse.
Consult your salon professional for additional Mediceuticals scalp and
hair treatments
specifically tailored for your condition.
INACTIVE INGREDIENTS
Water (Aqua), Sodium Olefin Sulfonate, Decyl Glucoside, Cocamide MEA,
Cocamidopropyl Hydroxysultaine, Zinc Pyrithione, Phenoxyethanol,
Sodium Chloride,
Climbazole, Polyquaternium-10 Panthenol, Allantoin, Fragrance
(Parfum).
X FOLATE
zinc pyrithione shampoo
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:59279-506
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R95