X FOLATE

Manufacturer: Mediceutical Laboratories, LTD
Effective date: 2022-01-13
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:46:50

Label at a glance#

ProductX FOLATE

Active ingredientPYRITHIONE ZINC

Label structure8 sections

Indications and uses

Helps control and prevent flaking & itching associated with dandruff and seborrheic dermatitis.

Dosage and administration

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. Apply shampoo to wet hair, massage into hair and scalp, leave on for 2-3 minutes. Thoroughly rinse and repeat if desired. Apply Therapeutic scalp and hair treatment rinse for 2-3 minutes, thoroughly rinse. Consult your salon professional for additional Mediceuticals scalp an...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

1% ZINC PYRITHIONE

PURPOSE

OTC - PURPOSE SECTION

Anti-dandruff, anti-psoriasis & anti-seborrheic dermatitis.

USES

INDICATIONS & USAGE SECTION

Helps control and prevent flaking & itching associated with dandruff and seborrheic dermatitis.

WARNINGS

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

Apply shampoo to wet hair, massage into hair and scalp, leave on for 2-3 minutes.
Thoroughly rinse and repeat if desired.
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

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium Olefin Sulfonate, Decyl Glucoside, Cocamide MEA, Cocamidopropyl Hydroxysultaine, Zinc Pyrithione, Phenoxyethanol, Sodium Chloride, Climbazole, Polyquaternium-10 Panthenol, Allantoin, Fragrance (Parfum).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_X-Folate_Zinc P 1pct_1-L_front

01b LBL_X-Folate_Zinc P 1pct_1-L_back

01b LBL_X-Folate_Zinc P 1pct_250mL_front

01b LBL_X-Folate_Zinc P 1pct_250mL_back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
209884	zinc pyrithione 1 % Medicated Shampoo	PSN	4
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	4
209884	zinc pyrithione 1 % Medicated Conditioner	SY	4
209884	zinc pyrithione 1 % Medicated Shampoo	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59279-506-08	2024-01-30	C162847	48780-1	1030e365-1523-111a-e063-dadaa90a10e2	Mediceutical Laboratories - MEDICEUTICALS X-FOLATE (59279-506)
59279-506-33	2024-01-30	C162847	48780-1	1030e365-1523-111a-e063-dadaa90a10e2	Mediceutical Laboratories - MEDICEUTICALS X-FOLATE (59279-506)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59279-506-08	X FOLATE	250 mL in 1 BOTTLE	SHAMPOO	250		4
59279-506-33	X FOLATE	1000 mL in 1 BOTTLE	SHAMPOO	1000		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59279-506	X FOLATE (ZINC PYRITHIONE) SHAMPOO [MEDICEUTICAL LABORATORIES, LTD]	4	Legacy NDC, 2 package rows	20220114_b4000706-acbe-4d55-97f9-6f003fe6cf5a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

X FOLATE
ZINC PYRITHIONE
WATER
SODIUM C14-16 OLEFIN SULFONATE
DECYL GLUCOSIDE
COCO MONOETHANOLAMIDE
COCAMIDOPROPYL HYDROXYSULTAINE
PHENOXYETHANOL
SODIUM CHLORIDE
CLIMBAZOLE
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)
PANTHENOL
ALLANTOIN
PYRITHIONE ZINC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59279-506	59279-506-33, 59279-506-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SODIUM C14-16 OLEFIN SULFONATE	O9W3D3YF5U	IACT
DECYL GLUCOSIDE	Z17H97EA6Y	IACT
COCO MONOETHANOLAMIDE	C80684146D	IACT
COCAMIDOPROPYL HYDROXYSULTAINE	62V75NI93W	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
CLIMBAZOLE	9N42CW7I54	IACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)	GMR4PEN8PK	IACT
PANTHENOL	WV9CM0O67Z	IACT
ALLANTOIN	344S277G0Z	IACT
PYRITHIONE ZINC	R953O2RHZ5	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d580e439-2711-74b2-e053-2995a90a513c			b4000706-acbe-4d55-97f9-6f003fe6cf5a	2022-01-13	Warnings	Exact identifier spl id: d580e439-2711-74b2-e053-2995a90a513c spl set id: b4000706-acbe-4d55-97f9-6f003fe6cf5a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.