TOPCARE

Manufacturer: TOPCO ASSOCIATES LLC | APOLLO HEALTH AND BEAUTY CARE
Effective date: 2014-11-18
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:40:51

Label at a glance#

ProductTOPCARE MEDICATED DANDRUFF

Active ingredientSELENIUM SULFIDE

Label structure7 sections

Indications and uses

FOR THE RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RECURRENCE

Dosage and administration

SHAKE WELL, APPLY SHAMPOO AND RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

Storage and handling

STORE AT ROOM TEMPERATURE

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

SELENIUM SULFIDE 1%

PURPOSE

OTC - PURPOSE SECTION

ANTI-DANDRUFF/ANTI-SEBORRHEIC DERMATITIS

USES

INDICATIONS & USAGE SECTION

FOR THE RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RECURRENCE

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYE THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY

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 ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

SHAKE WELL, APPLY SHAMPOO AND RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

OTHER INFORMATION

STORAGE AND HANDLING SECTION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER (AQUA), SODIUM LAURETH SULFATE, TEA-LAURYL SULFATE, COCAMIDOPROPYL BETAIN, ACRYLATES COPOLYMER, CITRIC ACID, FRAGRANCE (PARFUM), AMMONIUM CHLORIDE, DMDM HYDANTOIN, MENTHOL, SODIUM HYDROXIDE, MAGNESIUM ALUMINUM SILICATE, HYDROXYPROPYL METHYLCELLULOSE, 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
204642	selenium sulfide 1 % Medicated Shampoo	PSN	1
204642	selenium sulfide 10 MG/ML Medicated Shampoo	SCD	1
204642	selenium sulfide 1 % Lotion Shampoo	SY	1
204642	selenium sulfide 1 % Medicated Shampoo	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-719-11	2020-01-31	C162847	48780-1	9d75b9d0-65f8-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-719-11	TOPCAREMEDICATED DANDRUFF	325 mL in 1 PACKAGE	LIQUID	325		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-719	TOPCARE MEDICATED DANDRUFF (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]	1	Legacy NDC, 1 package rows	20141119_c6f8c18a-bdab-4b0f-824d-7d32a21b668f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SELENIUM SULFIDE	ACTIVE INGREDIENT	Z69D9E381Q	1
SELENIUM SULFIDE	ACTIVE MOIETY	Z69D9E381Q	1
AMMONIUM CHLORIDE	INACTIVE INGREDIENT	01Q9PC255D	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	1
TEA-LAURYL SULFATE	INACTIVE INGREDIENT	E8458C1KAA	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

TOPCARE MEDICATED DANDRUFF
SELENIUM SULFIDE
WATER
SODIUM LAURETH SULFATE
TEA-LAURYL SULFATE
COCAMIDOPROPYL BETAINE
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
CITRIC ACID MONOHYDRATE
AMMONIUM CHLORIDE
DMDM HYDANTOIN
MENTHOL
SODIUM HYDROXIDE
MAGNESIUM ALUMINUM SILICATE
HYPROMELLOSES
FD&C BLUE NO. 1
D&C RED NO. 33

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-719	36800-719-11

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
SELENIUM SULFIDE	Z69D9E381Q	ACTIB
WATER	059QF0KO0R	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
TEA-LAURYL SULFATE	E8458C1KAA	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	74G4R6TH13	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
AMMONIUM CHLORIDE	01Q9PC255D	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
MENTHOL	L7T10EIP3A	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
HYPROMELLOSES	3NXW29V3WO	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 7 · 403 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	TABLET, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SHAMPOO / TOPICAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
AMMONIUM CHLORIDE	AMMONIUM CHLORIDE	01Q9PC255D	TABLET, FILM COATED / ORAL	8 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / IONTOPHORESIS	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	PASTE / DENTAL	0.6 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTABLE, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / RESPIRATORY (INHALATION)	8 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBMUCOSAL	ADJ PH		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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	DROPS / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		38 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	221 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYRUP / ORAL	722 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INFILTRATION	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	ELIXIR / ORAL	100 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INFILTRATION	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETHRAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SHAMPOO / TOPICAL	3 %w/w		Exact identifier — unii candidate 27 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
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATHECAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVENOUS		78 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	JELLY / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INHALANT / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CREAM / TOPICAL	3 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	74G4R6TH13	CAPSULE, EXTENDED RELEASE / ORAL		225 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION/ DROPS / ORAL		19 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION / RECTAL		14480 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	INSERT / VAGINAL	54.21 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / RESPIRATORY (INHALATION)	0.13 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SOLUTION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, ORALLY DISINTEGRATING / ORAL		41 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
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
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GEL / RECTAL		348 mg	Exact identifier — unii candidate 27 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
1a4c451e-c0f9-45c9-a878-363e61169765			c6f8c18a-bdab-4b0f-824d-7d32a21b668f	2014-11-18	Warnings	Exact identifier spl id: 1a4c451e-c0f9-45c9-a878-363e61169765 spl set id: c6f8c18a-bdab-4b0f-824d-7d32a21b668f

Reported adverse events (FAERS/openFDA)#

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