FDA.reportPublic FDA data

Royal Dandruff

Manufacturer
Mission Series Inc. dba Prestige Beauty Care
Effective date
2020-05-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:13:44

Label at a glance#

ProductRoyal Dandruff
Active ingredientPYRITHIONE ZINC
Label structure12 sections

Dosage and administration

Directions - 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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient - Pyrithione Zinc 1%

Purpose

OTC - PURPOSE SECTION

Purpose - Anti-dandruff

Use

INDICATIONS & USAGE SECTION

Use - helps purify scalp and hair to restore natural shine.

Warnings

WARNINGS SECTION

Warnings - For external use only.

Warnings

WARNINGS SECTION

Warnings - For external use only.

When using this product

OTC - WHEN USING SECTION

When using this product

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

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if

- 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

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

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

- 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients - Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocoamide MEA, Zinc Carbonate, Glycol Distearate, Dimethicone, Cetyl Alcohol, Guar Hydroxypropyltrimonium Chloride, Magnesium Sulfate, Sodium Benzoate, Magnesium Carbonate Hydroxide, Ammonium Laureth Sulfate, Benzyl Alcohol, Sodium Chloride, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Xylenesulfonate, Menthol, Yellow 5, Blue 1.

Distributed By

SPL UNCLASSIFIED SECTION

Distributed By:

PRESTIGE BEAUTY CARE

1585 West Mission Blvd.

Pomona, CA 91766

Made in China

Royal Dandruff Shampoo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Royal Dandruff ShampooRoyal Dandruff Shampoo

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN2
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD2
209884zinc pyrithione 1 % Medicated ConditionerSY2
209884zinc pyrithione 1 % Medicated ShampooSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73597-008-102022-01-28C16284748780-1d6a99b39-3d5b-a426-e053-dadaa90af4c2Royal Dandruff

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73597-008-10Royal Dandruff273.06 g in 1 BOTTLESHAMPOO273.062

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73597-008ROYAL DANDRUFF (PYRITHIONE ZINC) SHAMPOO [MISSION SERIES INC. DBA PRESTIGE BEAUTY CARE]2Legacy NDC, 1 package rows20200520_a513fe20-5750-74af-e053-2a95a90ac207.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73597-00873597-008-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
ZINC CARBONATEEQR32Y7H0MIACT
GLYCOL DISTEARATE13W7MDN21WIACT
DIMETHICONE92RU3N3Y1OIACT
CETYL ALCOHOL936JST6JCNIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
MENTHOLL7T10EIP3AIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
TEA TREE OILVIF565UC2GIACT
WATER059QF0KO0RIACT
COCO MONOETHANOLAMIDEC80684146DIACT
BENZYL ALCOHOLLKG8494WBHIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
SODIUM CHLORIDE451W47IQ8XIACT

Source Document#

Source XML · Source PDF

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a608ff8f-4f78-6134-e053-2a95a90a17d6a513fe20-5750-74af-e053-2a95a90ac2072020-05-19WarningsExact identifier
spl id: a608ff8f-4f78-6134-e053-2a95a90a17d6
spl set id: a513fe20-5750-74af-e053-2a95a90ac207

Reported adverse events (FAERS/openFDA)#

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