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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59279-514
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID 
FD&C BLUE NO. 1 
CAPRYLYL GLYCOL 
CETOSTEARYL ALCOHOL 
MATRICARIA RECUTITA 
OCTINOXATE 
GINKGO 
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 
HEXYLENE GLYCOL 
HOPS 
GOLDENSEAL 
MENTHOL 
PHENOXYETHANOL 
ROSEMARY 
EDETATE SODIUM 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59279-514-331000 mL in 1 BOTTLE, PLASTIC
2NDC:59279-514-12360 mL in 1 BOTTLE, PLASTIC
3NDC:59279-514-06180 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/01/2007
Labeler - Mediceutical Laboratories, LTD (136770067)
Registrant - Mediceutical Laboratories, LTD (136770067)
Establishment
NameAddressID/FEIBusiness Operations
United 1 International Laboratories807878116manufacture(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