FDA.reportPublic FDA data

Royal Dandruff Dry Scalp Care

Manufacturer
Mission Series Inc. dba Prestige Beauty Care | PATCOS COSMETICS (INDIA) PRIVATE LIMITED
Effective date
2023-07-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:41

Label at a glance#

ProductRoyal Dandruff Dry Scalp Care
Active ingredientPYRITHIONE ZINC
Label structure11 sections

Dosage and administration

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

 Pyrithione Zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Use

INDICATIONS & USAGE SECTION

helps protect the scalp's natural moisture balance and gives you great looking hair.   

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

do not get into 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 as directed.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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, Gaur Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Citric Acid, Prunus Amygdalus dulcis ( Sweet Almond )Oil, Methylchloroisothiazolinone, Methylisothiazolinone, FD & C Blue No. 1, Cl No. 42090

SPL UNCLASSIFIED SECTION

Distributed By:

PRESTIGE BEAUTY CARE

1585 West Mission Blvd.

Pomona, CA 91766

Made in India

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD1
209884zinc pyrithione 1 % Medicated ConditionerSY1
209884zinc pyrithione 1 % Medicated ShampooSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73597-026-102025-01-30C16284748780-11030e365-3d40-111a-e063-dadaa90a10e2f883af96-9aaf-4d83-9905-0d2b27e511c2
73597-026-102024-09-24C16284748780-11030e365-3d40-111a-e063-dadaa90a10e2f883af96-9aaf-4d83-9905-0d2b27e511c2
73597-026-102024-07-30C16284748780-11030e365-3d40-111a-e063-dadaa90a10e2f883af96-9aaf-4d83-9905-0d2b27e511c2
73597-026-102024-01-30C16284748780-11030e365-3d40-111a-e063-dadaa90a10e2f883af96-9aaf-4d83-9905-0d2b27e511c2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73597-026-10Royal Dandruff Dry Scalp Care24 in 1 CARTONSHAMPOO241
73597-026-10Royal Dandruff Dry Scalp Care296 mL in 1 BOTTLESHAMPOO2961

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73597-026ROYAL DANDRUFF DRY SCALP CARE (PYRITHIONE ZINC) SHAMPOO [MISSION SERIES INC. DBA PRESTIGE BEAUTY CARE]12 package rows20230720_f883af96-9aaf-4d83-9905-0d2b27e511c2.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
73597-02673597-026-10

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
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO MONOETHANOLAMIDEC80684146DIACT
GLYCOL STEARATE0324G66D0EIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
SODIUM CHLORIDE451W47IQ8XIACT
ZINC CARBONATEEQR32Y7H0MIACT
DIMETHICONE92RU3N3Y1OIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
SODIUM BENZOATEOJ245FE5EUIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALMOND OIL66YXD4DKO9IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

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
00d7203d-fdb7-951c-e063-6394a90ae46bf883af96-9aaf-4d83-9905-0d2b27e511c22023-07-19WarningsExact identifier
spl id: 00d7203d-fdb7-951c-e063-6394a90ae46b
spl set id: f883af96-9aaf-4d83-9905-0d2b27e511c2

Reported adverse events (FAERS/openFDA)#

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