Label: THERA RX- triclosan solution
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Contains inactivated NDC Code(s)
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
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.
Drug Label Information
Updated October 1, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Keep this and all drugs out of reach of children.
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Directions
For persistent dandruff and psoriasis conditions:
- Apply Thera RxTM directly to dry scalp
- 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.
For Excessive oily scalp and seborrheic dermatitis conditions use Solv-XTM 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 WASHMEDICEUTICALS®
Cruelty Free. Not tested on Animals.
Sold exclusively through fine Salons, Spas and Hair Restoration ClinicsManufactured in the USA for:
Mediceutical Laboratories, LTD Fort Worth, Texas 76118
Customer Service: 1-800-433-2903Mediceutical Europe B.V.
Kelvinstraat 61, 2723 RJ Zoetermeer, The Netherlands EU
Telephone: +31 79 3314029
NDC 5927953006 THERA RxTM 6 fl oz
NDC 5927953012 THERA RxTM 12 fl oz
Front
Back
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INGREDIENTS AND APPEARANCE
THERA RX
triclosan solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59279-530 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength ACETIC MONOETHANOLAMIDE (UNII: A9O0818TWD) ASCORBIC ACID (UNII: PQ6CK8PD0R) BIOTIN (UNII: 6SO6U10H04) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) SARCOSINE (UNII: Z711V88R5F) OCTINOXATE (UNII: 4Y5P7MUD51) LINOLEIC ACID (UNII: 9KJL21T0QJ) LINOLENIC ACID (UNII: 0RBV727H71) MENTHOL (UNII: L7T10EIP3A) PANTHENOL (UNII: WV9CM0O67Z) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) JOJOBA OIL (UNII: 724GKU717M) SORBITOL (UNII: 506T60A25R) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) WHEAT GERM OIL (UNII: 14C97E680P) WATER (UNII: 059QF0KO0R) ZINC SULFATE (UNII: 89DS0H96TB) 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)