FDA.reportPublic FDA data

XtraCare Dandruff Hair Wash

Manufacturer
Rejoice International | China Ningbo Shangge Cosmetic Technology Corp
Effective date
2024-02-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:09:05

Label at a glance#

ProductXtraCare Dandruff Hair Wash
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                Purpose

Salicylic Acid 3% ........................... Anti-dandruff

OTC - PURPOSE SECTION

Uses

for relief of flaking and itching due to dandruff and sebhorreic dermatitis, and to help prevent their recurrence

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

*compare to active ingredients in Selsun Blue® naturals dandruff shampoo

XtraCare® Dandruff Shampoo Salicylic Acid 3%

Controls Flakes & Itch

  • Intensive Moisturizers
  • Enriched with Vitamin B5

11 Fl Oz (325 mL)

WARNINGS SECTION

Warnings

For external use only

Ask a doctor before use if you have

  • sebhorreic dermatitis in areas other than the scalp

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

  • shampoo, then rinse thoroughly
  • for best results, use at least twice a week or as directed by a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients: water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, cocamide MEA, fragrance, polyquaternium-10, disodium EDTA, citric acid, benzyl alcohol, panthenol (pro-vitamin B5), triclosan, fd&c blue no.1

OTHER SAFETY INFORMATION

Other Information store at room temperature

Questions/Comments? 1-855-345-5575

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Selsun Blue® Naturals Dandruff Shampoo.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168, USA

MADE IN CHINA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
205023salicylic acid 3 % Medicated ShampooPSN3
205023salicylic acid 30 MG/ML Medicated ShampooSCD3
205023salicylic acid 3 % Medicated ShampooSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-053-012024-02-28C16284748780-11030e365-218a-111a-e063-dadaa90a10e2XtraCare Dandruff Hair Wash
57337-053-012024-01-30C16284748780-11030e365-218a-111a-e063-dadaa90a10e2XtraCare Dandruff Hair Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-053-01XtraCare Dandruff Hair Wash325 g in 1 BOTTLESHAMPOO3253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-053XTRACARE DANDRUFF HAIR WASH (SALICYLIC ACID) SHAMPOO [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_1902e6bb-e829-4b1a-b85a-1394913c77ca.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146D1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)INACTIVE INGREDIENTGMR4PEN8PK1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP01
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
TRICLOSANINACTIVE INGREDIENT4NM5039Y5X1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-05357337-053-01

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
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO MONOETHANOLAMIDEC80684146DIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
EDETATE DISODIUM7FLD91C86KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZYL ALCOHOLLKG8494WBHIACT
PANTHENOLWV9CM0O67ZIACT
TRICLOSAN4NM5039Y5XIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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 · 14 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
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO / TOPICAL65 %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
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO / TOPICAL65 %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
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %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
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Dandruff Hair WashSALICYLIC ACIDRejoice International1902e6bb-e829-4b1a-b85a-1394913c77ca2024-02-28WarningsExact identifier
ndc (package): 57337-053-01
ndc (product): 57337-053
ndc11 (package): 57337005301
spl id: 126ce8d0-8cc7-35cf-e063-6294a90a450f
spl set id: 1902e6bb-e829-4b1a-b85a-1394913c77ca

Reported adverse events (FAERS/openFDA)#

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