FDA.reportPublic FDA data

Royal Dandruff Dry Scalp

Manufacturer
Mission Series Inc. dba Prestige Beauty Care
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:40

Label at a glance#

ProductRoyal Dandruff Dry Scalp
Active ingredientPYRITHIONE ZINC
Label structure11 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 protect the scalp's natural moisture balance and gives you great looking hair.

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 Lauryl Ether Sulfate, Sodium Lauryl Sulfate, Cocoamidopropyl Betaine, Cocomonoethanolamide, Ethylene Glycol Monostearate, Sodium Xylenesulfonate, Sodium Chloride, Zinc Carbonate, Dimethicone, Cetrimonium Chloride, Fragrance, Sodium Benzoate, Guar Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Citric Acid, Prunus Amygdalus dulcis (sweet Almond) oil, Methylchloroisothiazolinone, Methylisothiazolinone, FD & C Blue No. 1, Cl. No. 42090

Distributed By

SPL UNCLASSIFIED SECTION

Distributed By:

PRESTIGE BEAUTY CARE

1585 West Mission Blvd.

Pomona, CA 91766

Made in India

Royal Dandruff Shampoo Dry Scalp

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Royal Dandruff Dry ScalpRoyal Dandruff Dry Scalp

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
73597-020-102024-09-24C16284748780-11030e365-64b9-111a-e063-dadaa90a10e2Royal Dandruff Dry Scalp
73597-020-102024-07-30C16284748780-11030e365-64b9-111a-e063-dadaa90a10e2Royal Dandruff Dry Scalp
73597-020-102024-01-30C16284748780-11030e365-64b9-111a-e063-dadaa90a10e2Royal Dandruff Dry Scalp

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73597-020-10Royal Dandruff Dry Scalp273.06 g in 1 BOTTLESHAMPOO273.062

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73597-020ROYAL DANDRUFF DRY SCALP (PYRITHIONE ZINC) SHAMPOO [MISSION SERIES INC. DBA PRESTIGE BEAUTY CARE]21 package rows20250110_f54fee96-11d7-5242-e053-2995a90aab85.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
73597-02073597-020-10

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
GLYCOL STEARATE0324G66D0EIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
WATER059QF0KO0RIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
ZINC CARBONATEEQR32Y7H0MIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
ALMOND OIL66YXD4DKO9IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
SODIUM CHLORIDE451W47IQ8XIACT
COCO MONOETHANOLAMIDEC80684146DIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
SODIUM LAURYL SULFATE368GB5141JIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM BENZOATEOJ245FE5EUIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2b3beeb6-704e-5fe7-e063-6294a90a64f1f54fee96-11d7-5242-e053-2995a90aab852025-01-08WarningsExact identifier
spl id: 2b3beeb6-704e-5fe7-e063-6294a90a64f1
spl set id: f54fee96-11d7-5242-e053-2995a90aab85

Reported adverse events (FAERS/openFDA)#

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