X FOLATE- 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, United 1 International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

5% coal tar extract 0.75

Purpose

anti-dandruff, anti-psoriasis, anti-seborrheic dermatitis

Uses

Helps prevent and control itching and flaking associated with dandruff, psoriasis and seborrheic dermatitis

Warnings

For external use only. If condition worsens or does not improve after regular use of this product as directed, discontinue and consult a physician. If condition covers a large area of the body, consult your physician before using this product.

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with cool water.

Directions

For best results use at least twice a week or as directed by a physician.
For maximum control, use every time you shampoo.

1. Wet hair massage a liberal amount of X-FolateTM into the scalp and leave on for 1-2 minutes.
   
2. Thorough rinse and repeat if desired.
   

Apply TherapeuticTM Scalp and Hair Treatment Rinse for 1-2 minutes, thoroughly rinse. For persistent dandruff and psoriasis use TheraRxTM as a pre-shampoo treatment.
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, Polyquaterniuim-7, Polyquaternium-10, Polysorbate 80, Salicylic Acid, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua)

Package Label-Principal Display Panel

X-FOLATETM

PERSISTENT DANDRUFF AND PSORIASIS TREATMENT SHAMPOO

MEDICEUTICALS®

Cruelty Free. Not tested on Animals
Sold exclusively through fine Salons, Spas and Medical Hair Restoration Clinics
Manufactured in the USA for:
Mediceutical Laboratories, LTD Fort Worth, Texas 76118
Customer Service: 1-800-433-2903
Medicuetical Europe B.V.
Kelvinstraat 61, 2723 RJ Zoetermeer, The Netherlands EU
Telphone: +31 79 3314029

NDC: 5927950533 X-FOLATETM 33.8 oz

NDC: 5927950506 X-FOLATETM 6 oz

NDC: 5927950512 X-FOLATETM 12 oz
Front

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INGREDIENTS AND APPEARANCE

X FOLATE 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59279-505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SULISOBENZONE (UNII: 1W6L629B4K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
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)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59279-505-33	1000 mL in 1 BOTTLE, PLASTIC
2	NDC: 59279-505-12	360 mL in 1 BOTTLE, PLASTIC
3	NDC: 59279-505-06	180 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/01/1993

Labeler - Mediceutical Laboratories, LTD (136770067)

Registrant - Mediceutical Laboratories, LTD (136770067)

Establishment
Name	Address	ID/FEI	Business Operations
United 1 International Laboratories		807878116	manufacture(59279-505)