Your browser does not support JavaScript! THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]
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THERA RX (triclosan) solution
[Mediceutical Laboratories, LTD]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Active ingredient

Triclosan 0.3%

Purpose

Antibacterial

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.

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 TherapeuticTM Scalp and Hair Treatment Rinse 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.

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 RxTM 6 fl oz

NDC 5927953012 THERA RxTM 12 fl oz

Front

TheraRxFront

Back

TheraRxBack

THERA RX 
triclosan solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59279-530
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59279-530-12360 mL in 1 BOTTLE, PLASTIC
2NDC:59279-530-06180 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/1997
Labeler - Mediceutical Laboratories, LTD (136770067)
Registrant - Mediceutical Laboratories, LTD (136770067)
Establishment
NameAddressID/FEIBusiness Operations
United 1 International Laboratories807878116manufacture(59279-530)

Revised: 10/2012
 
Mediceutical Laboratories, LTD

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