THERA RX- triclosan solution

THERA RX by

Drug Labeling and Warnings

THERA RX by is a Otc medication manufactured, distributed, or labeled by Mediceutical Laboratories, LTD, United 1 International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Back

INGREDIENTS AND APPEARANCE

THERA RX 
triclosan solution

Product 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)