Cyzone

Manufacturer: VENTURA CORPORATION LTDA.,
Effective date: 2010-08-10
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:52:37

Label at a glance#

ProductCyzone Trax Coolture Dermo Cool

Active ingredientPyrithione zinc

Label structure9 sections

Indications and uses

Reduces the symptoms of dandruff

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 0.5%

Purpose

OTC - PURPOSE SECTION

Antidandruff shampoo

Uses

INDICATIONS & USAGE SECTION

Reduces the symptoms of dandruff

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

If condition worsens or does not improve after regular use of this product as directed, consult a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (water), sodium laureth sulfate, cocamide dea, cocamidopropyl betaine, dimethiconol, sodium chloride, parfum (fragrance), acrylates/c10-30 alkyl acrylate crosspolymer, glycol distearate, triethanolamine, guar hydroxypropyltrimonium chloride, coco-glucoside, tea-dodecylbenzenesulfonate, citric acid, , glyceryl stearate, , glyceryl oleate, magnesium nitrate, zinc chloride, hydrolyzed wheat protein, tocopheryl acetate, panthenol, menthyl pca, methylchloroisothiazolinone, magnesium chloride, methylisothiazolinone, menthol, dipropylene glycol, saccharomyces/sea salt ferment, ci 42090 (blue 1), ci 17200 (red 33), ci 19140 (yellow 5).

Questions?

OTC - QUESTIONS SECTION

Puerto Rico: 622-3235 (San José)

PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHAMPOO 2 EN 1
CONTROL CASPA

trax
coolture

DERMO COOL

cy°zone

300 ml e
(10.1 fl.oz.)

Principal Display Panel - 300 ml Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13537-301-60	2025-05-06	C162847	48780-1	956f9ecf-d434-621f-e053-dbdaa90a74ad	Trax Coolture Antidandruff Shampoo
13537-301-70	2025-05-06	C162847	48780-1	956f9ecf-d434-621f-e053-dbdaa90a74ad	Trax Coolture Antidandruff Shampoo
13537-301-60	2019-10-21	C162847	48780-1	956f9ecf-d434-621f-e053-dbdaa90a74ad	Trax Coolture Antidandruff Shampoo
13537-301-70	2019-10-21	C162847	48780-1	956f9ecf-d434-621f-e053-dbdaa90a74ad	Trax Coolture Antidandruff Shampoo

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Pyrithione zinc	ACTIVE INGREDIENT	R953O2RHZ5	1
Pyrithione zinc	ACTIVE MOIETY	R953O2RHZ5	1
alpha-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
chloride ion	INACTIVE INGREDIENT	Q32ZN48698	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
cocamidopropyl betaine	INACTIVE INGREDIENT	5OCF3O11KX	1
coco diethanolamide	INACTIVE INGREDIENT	92005F972D	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
dipropylene glycol	INACTIVE INGREDIENT	E107L85C40	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	1
glyceryl monooleate	INACTIVE INGREDIENT	4PC054V79P	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
glycol distearate	INACTIVE INGREDIENT	13W7MDN21W	1
magnesium chloride	INACTIVE INGREDIENT	02F3473H9O	1
magnesium nitrate	INACTIVE INGREDIENT	77CBG3UN78	1
menthol	INACTIVE INGREDIENT	L7T10EIP3A	1
methylchloroisothiazolinone	INACTIVE INGREDIENT	DEL7T5QRPN	1
methylisothiazolinone	INACTIVE INGREDIENT	229D0E1QFA	1
panthenol	INACTIVE INGREDIENT	WV9CM0O67Z	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	1
sodium laureth sulfate	INACTIVE INGREDIENT	BPV390UAP0	1
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	1
water	INACTIVE INGREDIENT	059QF0KO0R	1
wheat	INACTIVE INGREDIENT	4J2I0SN84Y	1
zinc chloride	INACTIVE INGREDIENT	86Q357L16B	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

Cyzone Trax Coolture Dermo Cool
Pyrithione zinc
water
sodium laureth sulfate
coco diethanolamide
cocamidopropyl betaine
sodium chloride
glycol distearate
trolamine
chloride ion
citric acid monohydrate
glyceryl monostearate
glyceryl monooleate
magnesium nitrate
zinc chloride
wheat
alpha-tocopherol acetate
panthenol
methylchloroisothiazolinone
methylisothiazolinone
magnesium chloride
menthol
dipropylene glycol
FD&C BLUE NO. 1
D&C RED NO. 33
FD&C YELLOW NO. 5

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13537-301	13537-301-60, 13537-301-70

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Pyrithione zinc	R953O2RHZ5	ACTIB
water	059QF0KO0R	IACT
sodium laureth sulfate	BPV390UAP0	IACT
coco diethanolamide	92005F972D	IACT
cocamidopropyl betaine	5OCF3O11KX	IACT
sodium chloride	451W47IQ8X	IACT
glycol distearate	13W7MDN21W	IACT
trolamine	9O3K93S3TK	IACT
chloride ion	Q32ZN48698	IACT
citric acid monohydrate	2968PHW8QP	IACT
glyceryl monostearate	230OU9XXE4	IACT
glyceryl monooleate	4PC054V79P	IACT
magnesium nitrate	77CBG3UN78	IACT
zinc chloride	86Q357L16B	IACT
wheat	4J2I0SN84Y	IACT
alpha-tocopherol acetate	9E8X80D2L0	IACT
panthenol	WV9CM0O67Z	IACT
methylchloroisothiazolinone	DEL7T5QRPN	IACT
methylisothiazolinone	229D0E1QFA	IACT
magnesium chloride	02F3473H9O	IACT
menthol	L7T10EIP3A	IACT
dipropylene glycol	E107L85C40	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 397 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii candidate 37 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
alpha-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
magnesium chloride	MAGNESIUM CHLORIDE	02F3473H9O	SOLUTION / INTRAOCULAR		15 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	CREAM / VAGINAL		56 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	SOLUTION / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		360 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	DROPS / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / EPIDURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
magnesium chloride	MAGNESIUM CHLORIDE	02F3473H9O	SOLUTION/ DROPS / OPHTHALMIC	0.03 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	EMULSION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRATHECAL		131 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATHECAL		9 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	PASTE, DENTIFRICE / DENTAL	4.7 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
coco diethanolamide	COCO DIETHANOLAMIDE	92005F972D	SOLUTION / TOPICAL	2.5 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ENDOTRACHEAL	7.6 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SYRUP / ORAL		1 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / ORAL	1 mg/1ml		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / ORAL		269 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
dipropylene glycol	DIPROPYLENE GLYCOL	E107L85C40	SYSTEM / TRANSDERMAL		6 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SOLUTION / ORAL		2 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / TOPICAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / OPHTHALMIC		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRALESIONAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / BUCCAL	0.11 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	GRANULE, FOR SUSPENSION / ORAL		162 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
347dc4a9-afcd-5f9b-e063-6294a90a2af6			dd7d2343-39e6-47a5-91d7-cdfb7fa1c793	2025-05-06	Warnings	Exact identifier spl set id: dd7d2343-39e6-47a5-91d7-cdfb7fa1c793

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.