FDA.reportPublic FDA data

XtraCare Foaming Hand Sanitizer

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 Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                    Purpose

Benzalkonium Chloride 0.13% .......... Antimicrobial

OTC - PURPOSE SECTION

Use:

to help reduce bacteria on the skin

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 immediately.

INDICATIONS & USAGE SECTION

XtraCare® Foaming Hand Sanitizer

Superior Protection

Alcohol Free

Kills 99.9% of germs

Clean Fresh Scent

7 FL OZ (207 mL)

WARNINGS SECTION

Warnings: for external use only.

When using this product  Avoid contact with eyes. In case of eye contact, flush with plenty of water. Avoid contact with broken skin.

Stop use and ask a doctor if skin iffitation develops.

DOSAGE & ADMINISTRATION SECTION

Directions

wet hands thoroughly with product and rub into skin until dry.

For children under 6, use only under adult supervision.

Not recommended for infancts.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: water, cetrimonium chloride, disodium cocoamphodiacetate, fragrance, glycerin, citric acid, dimethicone, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone.

OTHER SAFETY INFORMATION

Questions/Comments? 1-855-345-5575

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
1098199benzalkonium chloride 0.13 % Topical GelPSN3
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCD3
1098199benzalkonium chloride 0.13 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-057-012024-02-28C16284748780-11030e365-045d-111a-e063-dadaa90a10e2XtraCare Foaming Hand Sanitizer
57337-057-012024-01-30C16284748780-11030e365-045d-111a-e063-dadaa90a10e2XtraCare Foaming Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-057-01XtraCare Foaming Hand Sanitizer207 g in 1 PACKAGEGEL2073

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-057XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_3082cbbb-a0ed-45eb-a116-ad1c65357dd1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBP1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DISODIUM COCOAMPHODIACETATEINACTIVE INGREDIENT18L9G3U51M1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPN1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-05757337-057-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE SODIUMMP1J8420LUIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route
10 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii+route
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii+route
10 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DISODIUM COCOAMPHODIACETATEDISODIUM COCOAMPHODIACETATE18L9G3U51MSHAMPOO, SUSPENSION / TOPICAL5 %w/vExact identifier — unii+route
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii+route
10 equally ranked IID candidates
DISODIUM COCOAMPHODIACETATEDISODIUM COCOAMPHODIACETATE18L9G3U51MSHAMPOO, SUSPENSION / TOPICAL5 %w/vExact identifier — unii+route
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 Hand SanitizerBENZALKONIUM CHLORIDERejoice International3082cbbb-a0ed-45eb-a116-ad1c65357dd12024-02-28WarningsExact identifier
ndc (package): 57337-057-01
ndc (product): 57337-057
ndc11 (package): 57337005701
spl id: 126d7580-4eff-8635-e063-6294a90a77c0
spl set id: 3082cbbb-a0ed-45eb-a116-ad1c65357dd1

Reported adverse events (FAERS/openFDA)#

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