ZOLIDYNE- pyrithione zinc shampoo 
Topiderm, Inc.

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Zolidyne Shampoo

Drug Facts

Active ingredient

Zinc Pyrithione, 2%

Purpose

Antidandruff, Seborrheic Dermatitis

Uses

Warnings

For external use only

  • Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Massage into wet scalp, lather well and rinse, leaving lather on scalp for 3-5 minutes

Inactive ingredients

Ammonium Lauryl Sulfate, Citric Acid, Cocamidopropyl Betaine, Ethylene Glycol Distearate, FD&C Blue #1, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Lauramide MIPA, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Laureth Sulfate, Water.

PRINCIPAL DISPLAY PANEL - 200 ml Tube Label

DERMA
TOPIX

zolidyne
shampoo

Zinc Pyrithione, 2%

Net 6.7 fl. oz. (200 ml.)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

PRINCIPAL DISPLAY PANEL - 200 ml Tube Label
ZOLIDYNE 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51326-203-67200 mL in 1 TUBE; Type 0: Not a Combination Product01/22/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM03201/22/1993
Labeler - Topiderm, Inc. (049121643)
Registrant - Topiderm, Inc. (049121643)
Establishment
NameAddressID/FEIBusiness Operations
Topiderm, Inc.049121643MANUFACTURE(51326-203)
Establishment
NameAddressID/FEIBusiness Operations
Topix Pharmaceuticals, Inc.117745066PACK(51326-203)

Revised: 11/2019
Document Id: 34c76824-3047-41a6-805a-a17e63e0c019
Set id: 6d5eaecc-a3a1-4739-ae5b-66df4a15cd21
Version: 7
Effective Time: 20191120
 
Topiderm, Inc.