X-FOLATE PLUS- coal tar shampoo

X-FOLATE by

Drug Labeling and Warnings

X-FOLATE by is a Otc medication manufactured, distributed, or labeled by Mediceutical Laboratories, LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

5% coal tar soluble extract

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 a nd consult a physician. If condition covers large area of the body, consult your physician before using this product.

KEEP OUT OF REACH OF CHILDREN

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

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).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

X-FOLATE   PLUS
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59279-516
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SULISOBENZONE (UNII: 1W6L629B4K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DICETYLDIMONIUM CHLORIDE (UNII: 6F4SX2007N)
OCTINOXATE (UNII: 4Y5P7MUD51)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
MENTHOL (UNII: L7T10EIP3A)
OCTOCRYLENE (UNII: 5A68WGF6WM)
OLIVE OIL (UNII: 6UYK2W1W1E)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59279-516-33	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2021
2	NDC: 59279-516-08	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	03/11/2021

Labeler - Mediceutical Laboratories, LTD (080520685)

Registrant - Mediceutical Laboratories, LTD (080520685)