XtraCare Anti-Dandruff Hair Cleanse

Manufacturer
Rejoice International Inc. | China Ningbo Shangge Cosmetic Technology Corp.
Effective date
2024-02-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:09:09

Label at a glance#

ProductXtraCare Anti-Dandruff Hair Cleanse mint and eucalyptus
Active ingredientPYRITHIONE ZINC
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                              Purpose

Pyrithione zinc 0.5% .................. Anti-dandruff

OTC - PURPOSE SECTION

XtraCare Anti-Dandruff Shampoo + pyrithione zinc

nourishing coconut & shea butter

fight flakes leaving hair healthy & shiny

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.

INDICATIONS & USAGE SECTION

Uses helps prevent recurrence of flaking and itching associated with dandruff.

Gentle enough for everyday use. For best results, use with XtraCare nourishing coconut & shea butter conditioner.

WARNINGS SECTION

WARNINGS

For external use only

When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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

DOSAGE & ADMINISTRATION SECTION

Directions

Wet hair, massage onto scalp, rinse. Repeat if desired. For best results use at least twice a week or as directed by a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, cocamide MEA, lauryl methyl gluceth-10, glycerin, carbomer, DMDM hydantoin, fragrance, triethanolamine, disodium EDTA, cocos nucifera (coconut) fruit extract, shea nut butter.

OTHER SAFETY INFORMATION

Other information

store at 20°C to 25°C (68° to 77°F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-026-012024-02-28C16284748780-11030e365-32ea-111a-e063-dadaa90a10e2XtraCare Anti-Dandruff Hair Cleanse
57337-026-012024-01-30C16284748780-11030e365-32ea-111a-e063-dadaa90a10e2XtraCare Anti-Dandruff Hair Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-026-01XtraCare Anti-Dandruff Hair Cleansemint and eucalyptus400 mg in 1 BOTTLESHAMPOO4004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-026XTRACARE ANTI-DANDRUFF HAIR CLEANSE MINT AND EUCALYPTUS (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]4Current NDC, Legacy NDC, 1 package rows20240229_b05742fe-692f-45a3-9de0-5f3f08642d78.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ52
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ52
.BETA.-D-GLUCOPYRANOSEINACTIVE INGREDIENTJ4R00M814D2
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995L2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX2
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146D2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6622
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP02
SPEARMINTINACTIVE INGREDIENTJ7I2T6IV1N2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-02657337-026-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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 1 · 34 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
COCO MONOETHANOLAMIDECOCO MONOETHANOLAMIDEC80684146DSHAMPOO / TOPICAL4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
2 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NTABLET / ORAL0.09 mgExact identifier — unii candidate
8 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NTABLET, CHEWABLE / ORAL2.1 mgExact identifier — unii candidate
8 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NSOLUTION / ORAL0.04 ml/5mlExact identifier — unii candidate
8 equally ranked IID candidates
CARBOMER COPOLYMER TYPE ACARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MPOWDER / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NTABLET, CHEWABLE / ORAL2.1 mgExact identifier — unii candidate
8 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
2 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NTABLET / ORAL0.09 mgExact identifier — unii candidate
8 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NSOLUTION / ORAL0.04 ml/5mlExact identifier — unii candidate
8 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route
6 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NTABLET, ORALLY DISINTEGRATING / ORAL0.06 mgExact identifier — unii candidate
8 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MPOWDER / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
COCO MONOETHANOLAMIDECOCO MONOETHANOLAMIDEC80684146DSHAMPOO / TOPICAL4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NTABLET, ORALLY DISINTEGRATING / ORAL0.06 mgExact identifier — unii candidate
8 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE ACARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route
6 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptusPYRITHIONE ZINCRejoice International Inc.b05742fe-692f-45a3-9de0-5f3f08642d782024-02-28WarningsExact identifier
ndc (package): 57337-026-01
ndc (product): 57337-026
ndc11 (package): 57337002601
spl id: 126c756d-69d8-085d-e063-6294a90ae640
spl set id: b05742fe-692f-45a3-9de0-5f3f08642d78

Reported adverse events (FAERS/openFDA)#

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