XtraCare Anti-Dandruff Hair Cleanse

Manufacturer: Rejoice International Inc. | China Ningbo Shangge Cosmetic Technology Corp.
Effective date: 2025-04-09
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 00:58:58

Label at a glance#

ProductXtraCare Anti-Dandruff Hair Cleanse for normal hair

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)

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-028-01	2024-02-28	C162847	48780-1	1030e365-3fbf-111a-e063-dadaa90a10e2	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR
57337-028-01	2024-01-30	C162847	48780-1	1030e365-3fbf-111a-e063-dadaa90a10e2	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR SENSITIVE HAIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-028-01	XtraCare Anti-Dandruff Hair Cleansefor normal hair	400 mg in 1 BOTTLE	SHAMPOO	400		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-028	XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]	9	Current NDC, Legacy NDC, 1 package rows	20250411_b90e574c-933c-4f86-aadc-567ffbe6ea04.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	2
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	2
.BETA.-D-GLUCOPYRANOSE	INACTIVE INGREDIENT	J4R00M814D	2
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	2
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	2
COCO MONOETHANOLAMIDE	INACTIVE INGREDIENT	C80684146D	2
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	2
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

XtraCare Anti-Dandruff Hair Cleanse for normal hair
PYRITHIONE ZINC
WATER
SODIUM LAURETH SULFATE
COCAMIDOPROPYL BETAINE
SODIUM CHLORIDE
COCO MONOETHANOLAMIDE
.BETA.-D-GLUCOPYRANOSE
GLYCERIN
CARBOMER COPOLYMER TYPE A
DMDM HYDANTOIN
TROLAMINE
EDETATE DISODIUM
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57337-028	57337-028-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
COCO MONOETHANOLAMIDE	C80684146D	IACT
.BETA.-D-GLUCOPYRANOSE	J4R00M814D	IACT
GLYCERIN	PDC6A3C0OX	IACT
CARBOMER COPOLYMER TYPE A	71DD5V995L	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
TROLAMINE	9O3K93S3TK	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
FD&C BLUE NO. 1	H3R47K3TBD	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 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
COCO MONOETHANOLAMIDE	COCO MONOETHANOLAMIDE	C80684146D	SHAMPOO / TOPICAL	4 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DMDM HYDANTOIN	DMDM HYDANTOIN	BYR0546TOW	LOTION / TOPICAL		3 mg	Exact identifier — unii+route 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A	CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	71DD5V995L	LOTION / TOPICAL		21 mg	Exact identifier — unii+route 2 equally ranked IID candidates
COCO MONOETHANOLAMIDE	COCO MONOETHANOLAMIDE	C80684146D	SHAMPOO / TOPICAL	4 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A	CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	71DD5V995L	LOTION / TOPICAL		21 mg	Exact identifier — unii+route 2 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DMDM HYDANTOIN	DMDM HYDANTOIN	BYR0546TOW	LOTION / TOPICAL		3 mg	Exact identifier — unii+route 2 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SHAMPOO / TOPICAL		3192 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SHAMPOO / TOPICAL		3192 mg	Exact identifier — unii+route+dosage form 2 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
XtraCare Anti-Dandruff Hair Cleanse for normal hair	PYRITHIONE ZINC	Rejoice International Inc.	b90e574c-933c-4f86-aadc-567ffbe6ea04	2025-04-09	Warnings	Exact identifier ndc (package): 57337-028-01 ndc (product): 57337-028 ndc11 (package): 57337002801 spl id: 326589b6-e988-685f-e063-6394a90a77b3 spl set id: b90e574c-933c-4f86-aadc-567ffbe6ea04

Reported adverse events (FAERS/openFDA)#

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