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 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
XFolateFront

Back
XFolateBack

X FOLATE 
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59279-505
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (COAL TAR) COAL TAR50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SULISOBENZONE 
CAPRYLYL GLYCOL 
COCAMIDOPROPYL BETAINE 
OCTINOXATE 
HEXYLENE GLYCOL 
MAGNESIUM CHLORIDE 
MENTHOL 
OCTOCRYLENE 
OLIVE OIL 
PANTHENOL 
PHENOXYETHANOL 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) 
POLYSORBATE 80 
SALICYLIC ACID 
SODIUM LAURETH SULFATE 
.ALPHA.-TOCOPHEROL ACETATE, D- 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59279-505-331000 mL in 1 BOTTLE, PLASTIC
2NDC:59279-505-12360 mL in 1 BOTTLE, PLASTIC
3NDC:59279-505-06180 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/01/1993
Labeler - Mediceutical Laboratories, LTD (136770067)
Registrant - Mediceutical Laboratories, LTD (136770067)
Establishment
NameAddressID/FEIBusiness Operations
United 1 International Laboratories807878116manufacture(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