THERA RX - triclosan solution 
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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THERA Rx

Active ingredient

Triclosan 0.3%

Purpose

Antibacterial

Uses

Warnings

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

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 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.

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

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

THERA RX 
triclosan solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59279-530
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 10/2012
Document Id: c5838590-724c-40c4-8ebf-bf09a6404ca2
Set id: f83c2901-8709-4ed6-91e7-da77e136075e
Version: 1
Effective Time: 20121001
 
Mediceutical Laboratories, LTD