FDA.reportPublic FDA data

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 23:46:40

Label at a glance#

ProductX-FOLATE PLUS
Active ingredientCOAL TAR
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

5% coal tar soluble extract

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 a nd 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.

  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

INACTIVE INGREDIENT SECTION

Benzophenone-4, Caprylyl Glycol, Cocamidopropyl Betaine, Dicetyldimonium Chloride, Ethylhexyl Methoxycinnamate, Fragrance (Parfum), Hexylene Glycol, Magnesium Chloride, Menthol, Octocrylene, Olea Europea (Olive) Fruit Oil, Panthenol, Phenoxyethanol, Polyquaternium-7, Polyquaternium-10, Polysorbate 80, Salicylic Acid, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_X-Folate_8oz_Front01b LBL_X-Folate_8oz_Front

01b LBL_X-Folate_8oz_Back01b LBL_X-Folate_8oz_Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204681coal tar 5 % Medicated ShampooPSN4
204681coal tar 50 MG/ML Medicated ShampooSCD4
204681coal tar 5 % Medicated ShampooSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59279-516-082024-01-30C16284748780-11030e365-0260-111a-e063-dadaa90a10e2Mediceutical Laboratories - X-FOLATE PLUS (59279-516)
59279-516-332024-01-30C16284748780-11030e365-0260-111a-e063-dadaa90a10e2Mediceutical Laboratories - X-FOLATE PLUS (59279-516)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59279-516-08X-FOLATEPLUS250 mL in 1 BOTTLESHAMPOO2504
59279-516-33X-FOLATEPLUS1000 mL in 1 BOTTLESHAMPOO10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59279-516X-FOLATE PLUS (COAL TAR) SHAMPOO [MEDICEUTICAL LABORATORIES, LTD]4Legacy NDC, 2 package rows20220114_1797d6d4-f5d8-4178-b7ec-d64d97c6255f.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59279-51659279-516-33, 59279-516-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULISOBENZONE1W6L629B4KIACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DICETYLDIMONIUM CHLORIDE6F4SX2007NIACT
OCTINOXATE4Y5P7MUD51IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
MENTHOLL7T10EIP3AIACT
OCTOCRYLENE5A68WGF6WMIACT
OLIVE OIL6UYK2W1W1EIACT
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
POLYSORBATE 806OZP39ZG8HIACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
COAL TARR533ESO2ECACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d580d658-6540-39fe-e053-2a95a90a88301797d6d4-f5d8-4178-b7ec-d64d97c6255f2022-01-13WarningsExact identifier
spl id: d580d658-6540-39fe-e053-2a95a90a8830
spl set id: 1797d6d4-f5d8-4178-b7ec-d64d97c6255f

Reported adverse events (FAERS/openFDA)#

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