FDA.reportPublic FDA data

XtraCare Antibacterial Hand Cleanse

Product NDC
57337-020
11-digit product format
573370020
Labeler code
57337
Product ID
57337-020_126c5107-3eeb-f016-e063-6294a90a07d4
Type
HUMAN OTC DRUG
Nonproprietary name
Triclosan
Dosage form
SOAP
Route
TOPICAL
Labeler
Rejoice International, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-03
Substance
TRICLOSAN
Active strength
3.3 mg/221mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
XtraCare Antibacterial Hand Cleanse
Brand name suffix
Mountain Spring
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRICLOSAN3.3 mg/221mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NM5039Y5XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020118Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c31723d5-a313-448a-8b69-ca5f8dec25edAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-020-012024-02-28C16284748780-11030e365-3025-111a-e063-dadaa90a10e2XtraCare Antibacterial Hand Cleanse
57337-020-012024-01-30C16284748780-11030e365-3025-111a-e063-dadaa90a10e2XtraCare Antibacterial Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-020-01XtraCare Antibacterial Hand CleanseMountain Spring221 mL in 1 BOTTLESOAP2215

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
TRICLOSANACTIVE MOIETY4NM5039Y5XXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-020XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]5Current NDC, Legacy NDC, 1 package rows20240229_c31723d5-a313-448a-8b69-ca5f8dec25ed.zip

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 13 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pistachio GlowETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5599605b-28f0-a534-e063-6394a90a72132026-07-01WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin CreamETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC559987c0-7abd-13fc-e063-6294a90a9f272026-07-01WarningsExact identifier
application number: M003
MISTIFY STRAWBERRE HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5740a2ed-e77d-3f41-e063-6394a90aec032026-07-01WarningsExact identifier
application number: M003
MISTIFY VANILLA HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574ba9b9-b44d-b014-e063-6394a90af7682026-07-01WarningsExact identifier
application number: M003
MISTIFY COTTON CANDY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574bcf4f-ad36-5ede-e063-6294a90a0eab2026-07-01WarningsExact identifier
application number: M003
MISTIFY COCONUT HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd57539bdd-641d-3c27-e063-6394a90af84a2026-07-01WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEHudson Health LLC42789576-0ab4-1afb-e063-6294a90a1d272026-06-30WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing Spray, Sugared PlumETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.5572d336-f953-90ac-e063-6394a90a2d4d2026-06-30WarningsExact identifier
application number: M003
McKesson Alcohol Prep PadISOPROPYL ALCOHOLMcKesson Medical-Surgicala8e759f3-91b1-44ae-960a-3a6cd4f746ce2026-06-30WarningsExact identifier
application number: M003
Tinted Isopropyl AlcoholISOPROPYL ALCOHOLMedical Chemical Corporationf3c1c8a3-6b34-46cf-845e-c89db8f096f12026-06-30WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMedical Chemical Corporationa04239d8-0fa9-4c00-aa81-d7a1242bc9312026-06-30WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry CrumbleETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.555da50d-f106-f27f-e063-6294a90a61f92026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach SandalwoodETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.55601f99-b1a7-ffb5-e063-6394a90a37d62026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti CupcakeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.556073a0-242b-dc26-e063-6394a90a9ccf2026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin CreamETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.55709e6c-e2ec-9c16-e063-6394a90a269e2026-06-29WarningsExact identifier
application number: M003
MedPride Alcohol WipesISOPROPYL ALCOHOLShield Line LLCad2a29b2-0511-bbe4-e053-2a95a90ac0b12026-06-29WarningsExact identifier
application number: M003
Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLPharma Nobis, LLCe42df0bf-cce7-3961-e053-2995a90a730a2026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry CremeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.556f24a7-2294-424f-e063-6394a90a0b682026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Gingerbread CakeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.556fa2a3-38de-1393-e063-6294a90add6a2026-06-29WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Matcha MistETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.556fcd84-0b0d-ed0b-e063-6394a90a45eb2026-06-29WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020118triclosan 0.15 % Medicated Liquid SoapPSNc31723d5-a313-448a-8b69-ca5f8dec25ed5
1020118triclosan 1.5 MG/ML Medicated Liquid SoapSCDc31723d5-a313-448a-8b69-ca5f8dec25ed5
1020118triclosan 0.15 % Medicated Liquid SoapSYc31723d5-a313-448a-8b69-ca5f8dec25ed5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-020-0157337002001221 mL in 1 BOTTLE (57337-020-01) 221 ml2013-09-030000-00-00NoNoCurrent