Label: X FOLATE- coal tar shampoo

  • NDC Code(s): 59279-505-06, 59279-505-12, 59279-505-33
  • Packager: Mediceutical Laboratories, LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/12

If you are a consumer or patient please visit this version.

  • Active Ingredient

    5% coal tar extract 0.75
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  • Purpose

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

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  • Uses

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

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  • 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.

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  • 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.

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  • 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)

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  • 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

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  • INGREDIENTS AND APPEARANCE
    X FOLATE 
    coal tar shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59279-505
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COAL TAR (COAL TAR) COAL TAR 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 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)
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