THERAPEUTIC - pyrithione zinc rinse 
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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THERAPEUTIC

Active ingredient

Pyrithione Zinc 0.5%

Purpose

anti-dandruff, anti-seborrheic, dermatitis

Uses

Warnings

For external use only. If condition worsens or does not improve after regular use of this product as directed, discontinue and consult a physician. If condition covers a large area of the body, consult your physician before using this product.

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 best results use daily or until conditionis iunder control or as directed by a physician.  For maximum control use every time you shampoo.
  1. Cleanse with appropriate Mediceuticals® shampoo
  2. Work ample amount of TherapeuticTM Scalp and Hair Treatment Rinse evenly through hair, gently massage onto the scalp, leave on 1-2 minutes
  3. Thoroughly rinse

Consult your Salon professional for additional Mediceuticals® scalp and hair treatment specifically tailored for your condition.

Inactive ingredients

Ascorbic Acid (Vitamin C), Behentrimonium Methosulfate, Blue 1 (CL 42090), Capryly Glycol, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Extract, Ethylhexly Methoxycinnamate, Fragrance (Parfum), Gingko Biloba Root Extract, Guar Hydroxypropyltrimonium Chloride, Hamamelis Virginiana (Witch Hazel) Extract, Hexylene Glycol, Humulus Lupulus (Hops) Extract, Hydrastis Canadensis (Golden Seal) Extract, Menthol, Phenoxyethanol, Rosmarinius Officinalis (Rosemary) Extract, Tetrasodium EDTA, Wate (Aqua)

Package Label-Principal Display Panel

THERAPEUTICTM

SCALP AND HAIR TREATMENT RINSE

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 Zoetermmer The Netherlands EU

Telephone: +31 79 3314029

NDC 5927951433 THERAPEUTICTM 33.8 fl oz

NDC 5927951406 THERAPEUTICTM 6 fl oz

NDC 5927951412 THERAPEUTICTM 12 fl oz

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THERAPEUTIC 
pyrithione zinc rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59279-514
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
OCTINOXATE (UNII: 4Y5P7MUD51)  
GINKGO (UNII: 19FUJ2C58T)  
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
HOPS (UNII: 01G73H6H83)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
MENTHOL (UNII: L7T10EIP3A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ROSEMARY (UNII: IJ67X351P9)  
EDETATE SODIUM (UNII: MP1J8420LU)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59279-514-33 1000 mL in 1 BOTTLE, PLASTIC
2 NDC:59279-514-12 360 mL in 1 BOTTLE, PLASTIC
3 NDC:59279-514-06 180 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 01/01/2007
Labeler - Mediceutical Laboratories, LTD (136770067)
Registrant - Mediceutical Laboratories, LTD (136770067)
Establishment
Name Address ID/FEI Business Operations
United 1 International Laboratories 807878116 manufacture(59279-514)

Revised: 10/2012
Document Id: bb13fe13-32ce-4d7c-988e-1bfff481eee1
Set id: 1c44418a-737b-4846-b1ef-4a80a4f68738
Version: 1
Effective Time: 20121001
 
Mediceutical Laboratories, LTD