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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Mediceutical Laboratories - THERAPEUTIC (59279-514), DELIST

Active ingredient

Pyrithione Zinc 0.5%

Purpose

anti-dandruff, anti-seborrheic, dermatitis

Uses

  • Helps prevent recurrence of flaking and itching associated with dandruff and seborrheic dermatitis

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 Therapeutic 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

THERAPEUTIC TM

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 THERAPEUTIC TM 33.8 fl oz

NDC 5927951406 THERAPEUTIC TM 6 fl oz

NDC 5927951412 THERAPEUTIC TM 12 fl oz

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TherapeuticFront

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THERAPEUTIC 
pyrithione zinc rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59279-514
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59279-514-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/200705/12/2020
2NDC:59279-514-12360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/200705/12/2020
3NDC:59279-514-06180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/200705/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/01/200705/12/2020
Labeler - Mediceutical Laboratories, LTD (080520685)

Revised: 1/2022
 
Mediceutical Laboratories, LTD