FDA.reportPublic FDA data

XtraCare Foaming Facial Cleanser

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 00:09:06

Label at a glance#

ProductXtraCare Foaming Facial Cleanser
Active ingredientTRICLOSAN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                          Purpose

Triclosan 0.25% ........................... Antiseptic

OTC - PURPOSE SECTION

XtraCare (oil-free) foaming facial cleanser

medicated to kill problem-causing bacteria without overdrying

Compare to Clean & Clear® Foaming Facial Cleanser

8 fl. oz. (237 mL)

oil free foaming facial cleanser

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

Use  to help reduce bacteria on the skin

WARNINGS SECTION

Warnings For external use only

When using this product avoid contact with eyes.  if eye contact occurs, immediately flush with water.

Stop use and ask a doctor if

  • excessive skin irritation develops or condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

DOSAGE & ADMINISTRATION SECTION

Directions

mix in hands with water. Work into a foamy later. Smooth over face and neck. Rinse thoroughly.

OTHER SAFETY INFORMATION

Other Information

Do not store where water may enter bottle.

*This product is not manufactured or distributed by Johnson&Johnson, the distributor of clean&clear®foaming facial cleanser.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC.

NORTHVILLE, MI 48168 USA

MADE IN CHINA

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water, sodium c14-16 olefin sulfonate, cocamide betaine, glycerin, PEG-40 hydrogenated castor oil, fragrance, DMDM hydantoin, disodium EDTA, citric acid, methylparaben, propylparaben, fd&c yellow no.5, d&c red no.33

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-036-012024-02-28C16284748780-11030e365-0263-111a-e063-dadaa90a10e2XtraCare Foaming Facial Cleanser
57337-036-012024-01-30C16284748780-11030e365-0263-111a-e063-dadaa90a10e2XtraCare Foaming Facial Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-036-01XtraCare Foaming Facial Cleanser237 mg in 1 BOTTLEGEL2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-036XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_313fcd4a-8641-417e-bf0b-02359ad815fe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5X1
TRICLOSANACTIVE MOIETY4NM5039Y5X1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POLYOXYL 40 CASTOR OILINACTIVE INGREDIENT4ERD2076EF1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5U1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-03657337-036-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
POLYOXYL 40 CASTOR OIL4ERD2076EFIACT
DMDM HYDANTOINBYR0546TOWIACT
EDETATE DISODIUM7FLD91C86KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT
TRICLOSAN4NM5039Y5XACTIB

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 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYOXYL 40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact 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
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii+route
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
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 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
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route
6 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact 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
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
POLYOXYL 40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
2 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
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
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact 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 Foaming Facial CleanserTRICLOSANRejoice International313fcd4a-8641-417e-bf0b-02359ad815fe2024-02-28WarningsExact identifier
ndc (package): 57337-036-01
ndc (product): 57337-036
ndc11 (package): 57337003601
spl id: 126d79f0-68eb-8a53-e063-6294a90a6fe1
spl set id: 313fcd4a-8641-417e-bf0b-02359ad815fe

Reported adverse events (FAERS/openFDA)#

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