ZOLIDYNE- pyrithione zinc shampoo

Zolidyne by

Drug Labeling and Warnings

Zolidyne by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc., Topix Pharmaceuticals Inc, Topix Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Pyrithione, 2%

Purpose

Antidandruff, Seborrheic Dermatitis

Uses

• A gentle, specially formulated shampoo for the control of flaking and itching associated with dandruff or seborrheic dermatitis.

Warnings

For external use only

• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
• If condition worsens or does not improve after regular use of this product as directed, consult a doctor
• If condition covers a large area of the body, consult your doctor before using this product

• 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

• For best results, use at least twice a week or as directed by your doctor.

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

INGREDIENTS AND APPEARANCE

ZOLIDYNE 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-203-67	200 mL in 1 TUBE; Type 0: Not a Combination Product	01/22/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	01/22/1993

Labeler - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-203)