Royal dandruff Dry Scalp Care

Manufacturer: Filo America | NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.
Effective date: 2013-09-17
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:36:55

Label at a glance#

ProductRoyal dandruff Dry Scalp Care

Active ingredientPYRITHIONE ZINC

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Pyrithione Zinc 1% Anti-dandruff

OTC - PURPOSE SECTION

Help prevent the scalp's natural moisture balance and gives you great looking hair.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Do not get into eyes, if contact occurs, rinse eyes thoroughly with water.

INDICATIONS & USAGE SECTION

Shake well, wet hair, massage onto scalp. Rinse, repeat if desired.

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

For maximum dandruff control, use every time you shampoo.

WARNINGS SECTION

For external use only.

Stop use and ask a doctor if Condition worsens or does not improve after regular use as directed.

DOSAGE & ADMINISTRATION SECTION

apply as needed.

INACTIVE INGREDIENT SECTION

water, sodium laureth sulfate, cocamidopropyl betaine, sodium lauroamphoacetate, glycol stearate, acrylates/acrylamide copolymer, ammonium chloride, methylchloroisothiazolinone, methylisothiazolinone, fragrance, citric acid, guar hydroxypropyltrimonium chloride, titanium dioxide, disodium EDTA, zinc chloride, blue 1, yellow 5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50438-300-01	2020-01-31	C162847	48780-1	9d75b9cf-d481-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50438-300-01	Royal dandruff Dry Scalp Care	350 mL in 1 BOTTLE	SHAMPOO	350		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50438-300	ROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [FILO AMERICA]	1	Legacy NDC, 1 package rows	20130917_73ea659a-e1c3-4f0e-aa7e-e4c8342e06a3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	1
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	1
ammonium chloride	INACTIVE INGREDIENT	01Q9PC255D	1
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
cocamidopropyl betaine	INACTIVE INGREDIENT	5OCF3O11KX	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	1
glycol stearate	INACTIVE INGREDIENT	0324G66D0E	1
methylchloroisothiazolinone	INACTIVE INGREDIENT	DEL7T5QRPN	1
methylisothiazolinone	INACTIVE INGREDIENT	229D0E1QFA	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Royal dandruff Dry Scalp Care
PYRITHIONE ZINC
water
cocamidopropyl betaine
glycol stearate
CARBOMER COPOLYMER TYPE A
ammonium chloride
methylchloroisothiazolinone
methylisothiazolinone
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C YELLOW NO. 5

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50438-300	50438-300-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
water	059QF0KO0R	IACT
cocamidopropyl betaine	5OCF3O11KX	IACT
glycol stearate	0324G66D0E	IACT
CARBOMER COPOLYMER TYPE A	71DD5V995L	IACT
ammonium chloride	01Q9PC255D	IACT
methylchloroisothiazolinone	DEL7T5QRPN	IACT
methylisothiazolinone	229D0E1QFA	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
PYRITHIONE ZINC	R953O2RHZ5	ACTIB

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 4 · 233 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
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	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 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
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	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EXTENDED RELEASE / ORAL		45 mg	Exact identifier — unii candidate 88 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
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 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
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SWAB / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 88 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
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
glycol stearate	GLYCOL STEARATE	0324G66D0E	CREAM / TOPICAL	1 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 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
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SOFT TISSUE	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GRANULE, FOR SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / INTRAVENOUS	0.2 %w/v		Exact identifier — unii candidate 88 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
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 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
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
ammonium chloride	AMMONIUM CHLORIDE	01Q9PC255D	SYRUP / ORAL	131.68 mg/5ml		Exact identifier — unii candidate 5 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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRACARDIAC	1.05 %w/v		Exact identifier — unii candidate 88 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
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii candidate 88 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
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
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
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 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	SOLUTION/ DROPS / AURICULAR (OTIC)	0.04 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SYRUP / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 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
f132d80e-721f-4219-963e-43764aaa88bf			73ea659a-e1c3-4f0e-aa7e-e4c8342e06a3	2013-09-17	Warnings	Exact identifier spl id: f132d80e-721f-4219-963e-43764aaa88bf spl set id: 73ea659a-e1c3-4f0e-aa7e-e4c8342e06a3

Reported adverse events (FAERS/openFDA)#

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