TopCare

Manufacturer: TopCo Associates LLC | Apollo Health and Beauty Care Inc.
Effective date: 2017-05-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:49:45

Label at a glance#

ProductTopCare Gentle Dandruff Everyday Clean

Active ingredientPYRITHIONE ZINC

Label structure6 sections

Indications and uses

to help prevent recurrence of flaking and itching associated with dandruff.

Dosage and administration

for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp and rinse repeat if desired

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

to help prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

avoid contact with 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 of this product as directed.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidentla ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

for maximum dandruff control, use every time you shampoo
wet hair, massage onto scalp and rinse
repeat if desired

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Acrylates Copolymer, Glycol Distearate, Cocamidopropyl Betaine, Cocamide MEA, Laureth-4, Fragrance (Parfum), Sodium Hydroxide, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Label Copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
209884	zinc pyrithione 1 % Medicated Shampoo	PSN	1
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	1
209884	zinc pyrithione 1 % Medicated Conditioner	SY	1
209884	zinc pyrithione 1 % Medicated Shampoo	SY	1

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0036800145689	GTIN-13: 0036800145689 EAN-13: 0036800145689 GTIN-12: 036800145689 UPC-A: 036800145689 GTIN storage (14 digits): 00036800145689	19682L.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-427-13	2020-01-31	C162847	48780-1	9d75b9d0-299b-f424-e053-dadaa90a57ce	Drug Facts
36800-427-33	2020-01-31	C162847	48780-1	9d75b9d0-299b-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-427-13	TopCareGentle Dandruff Everyday Clean	420 mL in 1 BOTTLE, PLASTIC	LIQUID	420		1
36800-427-33	TopCareGentle Dandruff Everyday Clean	1000 mL in 1 BOTTLE, PLASTIC	LIQUID	1000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-427	TOPCARE GENTLE DANDRUFF EVERYDAY CLEAN (PYRITHIONE ZINC) LIQUID [TOPCO ASSOCIATES LLC]	1	Legacy NDC, 2 package rows	20170501_dc1048ba-6625-4813-8254-bb23bca75936.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

TopCare Gentle Dandruff Everyday Clean
Pyrithione Zinc
WATER
SODIUM LAURETH SULFATE
SODIUM CHLORIDE
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
GLYCOL DISTEARATE
COCAMIDOPROPYL BETAINE
COCO MONOETHANOLAMIDE
LAURETH-4
SODIUM HYDROXIDE
EDETATE SODIUM
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
FD&C BLUE NO. 1
D&C RED NO. 33

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-427	36800-427-13, 36800-427-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PYRITHIONE ZINC	R953O2RHZ5	ACTIB
WATER	059QF0KO0R	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	74G4R6TH13	IACT
GLYCOL DISTEARATE	13W7MDN21W	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
COCO MONOETHANOLAMIDE	C80684146D	IACT
LAURETH-4	6HQ855798J	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
EDETATE SODIUM	MP1J8420LU	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

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
47a3a1e7-0101-435f-af9d-df72952b19fb			dc1048ba-6625-4813-8254-bb23bca75936	2017-05-01	Warnings	Exact identifier spl id: 47a3a1e7-0101-435f-af9d-df72952b19fb spl set id: dc1048ba-6625-4813-8254-bb23bca75936

Reported adverse events (FAERS/openFDA)#

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