THERAPEUTIC- zinc pyrithione 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 SCALP & HAIR TREATMENT RINSE (59279-515)

Active ingredient

Pyrithione Zinc 1%

Purpose

anti-dandruff, anti-seborrheic, dermatitis

Uses

HELPS CONTROL AND PREVENT FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITUS.

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.

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with cool water.

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 TM 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

WATER (AQUA), BEHENTRIMONIUM METHOSULFATE, CETEARYL ALCOHOL, CETYL ALCOHOL, PHENOXYETHANOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HUMULUS LUPULUS (HOPS) EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, HYDRASTIS CANADENSIS (GOLDENSEAL) EXTRACT, HAMAMELIS VIRGINIANA (WITCH hAZEL) LEAF EXTRACT, ASCORBIC ACID, ETHYLHEXYL METHOXYCINNAMATE, TETRASODIUM EDTA, MENTHOL, GINKGO BILOBA, FRAGRANCE (PARFUM), BLUE 1 (CI 42090).

Therapeutic 250ml_FrontTherapeutic 250ml_Back

THERAPEUTIC 
zinc pyrithione rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59279-515
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
HOPS (UNII: 01G73H6H83)  
ROSEMARY (UNII: IJ67X351P9)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
WITCH HAZEL (UNII: 101I4J0U34)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
OCTINOXATE (UNII: 4Y5P7MUD51)  
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
MENTHOL (UNII: L7T10EIP3A)  
GINKGO BILOBA WHOLE (UNII: 660486U6OI)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59279-515-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2020
2NDC:59279-515-12250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/01/2007
Labeler - Mediceutical Laboratories, LTD (080520685)

Revised: 1/2022
Document Id: d580ee94-9382-1177-e053-2a95a90a99fe
Set id: db1dfe98-6eba-4dc1-a11a-845fe19ddc61
Version: 4
Effective Time: 20220113
 
Mediceutical Laboratories, LTD