X FOLATE- coal tar 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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X-FOLATE

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 Therapeutic TM Scalp and Hair Treatment Rinse for 1-2 minutes, thoroughly rinse. For persistent dandruff and psoriasis use TheraRx TM 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-FOLATE TM 33.8 oz

NDC 5927950506 X-FOLATE TM 6 oz

NDC 5927950512 X-FOLATE TM 12 oz
Front
XFolateFront

Back
XFolateBack

X FOLATE 
coal tar shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59279-505
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 10/2012
Document Id: 5481e2f4-08c6-46e2-a36e-d50b07da7b63
Set id: 59752625-60c4-4cbd-bcc7-2a0bc0979fa1
Version: 1
Effective Time: 20121001
 
Mediceutical Laboratories, LTD