Label: THERA RX - triclosan solution 

  • Label RSS
  • NDC Code(s): 59279-530-06, 59279-530-12
  • Packager: Mediceutical Laboratories, LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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

    Triclosan 0.3%

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  • Purpose

    Antibacterial

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  • Uses

    • Kills a broad spectrum of germs that may cause infections; first aid antiseptic to help prevent infection from minor cuts, scrapes, and burns. Promotes cleanliness and healing.
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  • Warnings

    For external use only. Do not apply over large areas of the body.

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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 persistent dandruff and psoriasis conditions:

    1. Apply Thera RxTM directly to dry scalp
    2. Gently work X-FolateTM Dandruff Treatment Shampoo onto the scalp, wrap the head within a hot towel, leave on 2-3 minutes, remove towel and thoroughly rinse. Reapply X-FolateTM working through the hair into a rich lather, leaving on for 1-2 minutes, thoroughly rinse.
    Apply Therapeutic TM Scalp and Hair Treatment Rinse for 1-2 minutes, thoroughly rinse.
    For Excessive oily scalp and seborrheic dermatitis conditions use Solv-X TM Oily Scalp Treatment Shampoo.
    Other Uses: Oily skin astringent cleanser, acne, burns, insect bites, sun and wind burns, scratches, and minor would treatment.
    Consult your Salon professional for additional Mediceuticals® scalp and hair treatments specifically tailored for your condition.
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  • Inactive ingredients

    Acetamide MEA, Ascorbic Acid (Vitamin C) Biotin, Blue1 (CI 42090), Camphor, Cocoyl Sarcosine, Ethylhexyl Methoxycinnamate, Fragrance (Parfum), Hydrolyzed Glycosaminoglycans, Hydrolyzed Keratin, Linoleic Acid, Linolenic Acid, Methanol, Panthenol, Polysorbate 80, Propylene Glycol, SD Alcohol 40-B, Simmondsia Chimensis (Jojoba) Seed Oil, Sodium Cocoyl Collagen Amino Acid, Sorbitol, Tocopheryl Acetate, Triticum Vulgare (Wheat) Germ Oil, Water (Aqua), Wheat Germ Acid, Zinc Sulfate

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  • Package Label-Principal Display Panel

    THERA RxTM

    ANTIBACTERIAL SCALP AND SKIN WASH

    MEDICEUTICALS®

    Cruelty Free. Not tested on Animals.

    Sold exclusively through fine Salons, Spas and Hair Restoration Clinics

    Manufactured in the USA for:

    Mediceutical Laboratories, LTD Fort Worth, Texas 76118

    Customer Service: 1-800-433-2903

    Mediceutical Europe B.V.

    Kelvinstraat 61, 2723 RJ Zoetermeer, The Netherlands EU

    Telephone: +31 79 3314029

    NDC 5927953006 THERA Rx TM 6 fl oz

    NDC 5927953012 THERA RxTM 12 fl oz

    Front

    TheraRxFront

    Back

    TheraRxBack

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  • INGREDIENTS AND APPEARANCE
    THERA RX 
    triclosan solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59279-530
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACETIC MONOETHANOLAMIDE  
    ASCORBIC ACID  
    BIOTIN  
    FD&C BLUE NO. 1  
    CAMPHOR (SYNTHETIC)  
    SARCOSINE  
    OCTINOXATE  
    LINOLEIC ACID  
    LINOLENIC ACID  
    MENTHOL  
    PANTHENOL  
    POLYSORBATE 80  
    PROPYLENE GLYCOL  
    ALCOHOL  
    JOJOBA OIL  
    SORBITOL  
    .ALPHA.-TOCOPHEROL ACETATE, D-  
    WHEAT GERM OIL  
    WATER  
    ZINC SULFATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59279-530-12 360 mL in 1 BOTTLE, PLASTIC
    2 NDC:59279-530-06 180 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 01/01/1997
    Labeler - Mediceutical Laboratories, LTD (136770067)
    Registrant - Mediceutical Laboratories, LTD (136770067)
    Establishment
    Name Address ID/FEI Business Operations
    United 1 International Laboratories 807878116 manufacture(59279-530)
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