Dandruff

Manufacturer: Topco Associates | Vi-Jon
Effective date: 2019-09-26
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 00:09:14

Label at a glance#

ProductDandruff

Active ingredientPYRITHIONE ZINC

Label structure9 sections

Dosage and administration

shake well for maximum dandruff control, use every time you shampoo wet hair massage onto scalp, rinse, repeat if desired for best results use at leat twice a week or as directed by a doctor

Contacts and useful links#

PhoneLabel contact1-888-423-0139

Label contents#

Full prescribing information#

claims

SPL UNCLASSIFIED SECTION

Dandruff Care for Great Looking Hair

Top Care Dandruff Shampoo Fresh Mint formula

helps relieve scalp dryness, itch, irritation and

helps prevent flakes, for clean manageable hair every day

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyritione zinc 1%

purpose

OTC - PURPOSE SECTION

Anti-dandruff

Use

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens or does not improve after regular use as directed

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

shake well
for maximum dandruff control, use every time you shampoo
wet hair massage onto scalp, rinse, repeat if desired
for best results use at leat twice a week or as directed by a doctor

inactive ingredients

INACTIVE INGREDIENT SECTION

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

disclaimer

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders refresh pyrithione zinc Dandruff Shampoo

Adverse reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD, SKOKIE, IL 60077
QUESTIONS? 1-888-423-0139

309.009/309AQ-AR

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOPCARE

GENTLE

dandruff shampoo

with pyrithione zinc

a cool refreshing

sensation and

hair is left clean and manageable

FRESH MINT

COMPARE TO

HEAD + SHOULDERS

14.2 FL OZ (420 mL)

image description

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	2
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	2
AMMONIUM LAURETH-3 SULFATE	INACTIVE INGREDIENT	896SJ235FN	2
AMODIMETHICONE (800 CST)	INACTIVE INGREDIENT	363Z2T48P7	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	2
CETRIMONIUM CHLORIDE	INACTIVE INGREDIENT	UC9PE95IBP	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	2
COCO MONOETHANOLAMIDE	INACTIVE INGREDIENT	C80684146D	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
FD&C RED NO. 4	INACTIVE INGREDIENT	X3W0AM1JLX	2
GLYCOL DISTEARATE	INACTIVE INGREDIENT	13W7MDN21W	2
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)	INACTIVE INGREDIENT	B16G315W7A	2
MAGNESIUM CARBONATE HYDROXIDE	INACTIVE INGREDIENT	YQO029V1L4	2
MAGNESIUM SULFATE	INACTIVE INGREDIENT	DE08037SAB	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	2
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	2
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	2
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	2
SODIUM XYLENESULFONATE	INACTIVE INGREDIENT	G4LZF950UR	2
TRIDECETH-12	INACTIVE INGREDIENT	YFY3KG5Y7O	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
ZINC CARBONATE	INACTIVE INGREDIENT	EQR32Y7H0M	2

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Dandruff
Pyrithione Zinc
WATER
SODIUM LAURYL SULFATE
SODIUM LAURETH SULFATE
GLYCOL DISTEARATE
SODIUM CHLORIDE
ZINC CARBONATE
SODIUM XYLENESULFONATE
AMODIMETHICONE (1300 CST)
COCAMIDOPROPYL BETAINE
SODIUM BENZOATE
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
MAGNESIUM CARBONATE HYDROXIDE
CITRIC ACID MONOHYDRATE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
FD&C BLUE NO. 1
D&C RED NO. 33

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-309	36800-309-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PYRITHIONE ZINC	R953O2RHZ5	ACTIB
WATER	059QF0KO0R	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
GLYCOL DISTEARATE	13W7MDN21W	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
ZINC CARBONATE	EQR32Y7H0M	IACT
SODIUM XYLENESULFONATE	G4LZF950UR	IACT
AMODIMETHICONE (1300 CST)	3V7U636DWN	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)	B16G315W7A	IACT
MAGNESIUM CARBONATE HYDROXIDE	YQO029V1L4	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
METHYLCHLOROISOTHIAZOLINONE	DEL7T5QRPN	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
D&C RED NO. 33	9DBA0SBB0L	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 10 · 560 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBCUTANEOUS	1 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PELLET / ORAL		2 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION / ORAL	705 mg		Exact identifier — unii candidate 42 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
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / INTRAMUSCULAR		225 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRALESIONAL		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED PELLETS / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / VAGINAL		100 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / TOPICAL		185 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE / ORAL	60 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii candidate 42 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
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-AMNIOTIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	136.55 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / TRANSDERMAL		472 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM / SUBLINGUAL	0.07 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	AEROSOL, FOAM / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRATHECAL		131 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER, FOR SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / EXTRACORPOREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ZINC CARBONATE	ZINC CARBONATE	EQR32Y7H0M	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	1.6 mg		Exact identifier — unii candidate
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SOFT TISSUE		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, DELAYED RELEASE / ORAL	0.25 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRALESIONAL		20 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / SUBLINGUAL	1.1 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ORAL		9 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LOTION, AUGMENTED / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 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
4a23ed1a-9e64-4f26-bace-24b870cac5e0			64e317c3-3fc2-4cb8-8c0c-8d567cce8f50	2020-09-11	Warnings, Adverse reactions	Exact identifier spl set id: 64e317c3-3fc2-4cb8-8c0c-8d567cce8f50

Reported adverse events (FAERS/openFDA)#

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