FDA.reportPublic FDA data

50563-351/352/353/354 G0XABW01

Manufacturer
ENCHANTE ACCESSORIES INC. | Zhejiang Ruolin Hygienic Products Co., Ltd.
Effective date
2020-10-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:10

Label at a glance#

Productbeauty concepts ANTIBACTERIAL HAND WIPES Coconut Vanilla Honey Almond Sugar Berry
Active ingredientBENZALKONIUM CHLORIDE
Label structure26 sections

Indications and uses

■ To decrease bacteria on hands

Dosage and administration

For adults and children two years and over Peel over reusable label and remove a wipe from the packet. Wet hands thoroughly and air dry. Place used wipes into waste basket. Do not flush.

Label contents#

Full prescribing information#

beauty concepts ANTIBACTERIAL HAND WIPES Coconut Vannilla

SPL UNCLASSIFIED SECTION

beauty concepts ANTIBACTERIAL HAND WIPES Coconut Vannilla

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

■ To decrease bacteria on hands

WARNINGS

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water

Stop use and ask a doctor if irritation or rash occurs. This may be signs of a serious condition

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 at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children two years and over

Peel over reusable label and remove a wipe from the packet.

Wet hands thoroughly and air dry.

Place used wipes into waste basket. Do not flush.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

beauty concepts ANTIBACTERIAL HAND WIPES Honey Almond

SPL UNCLASSIFIED SECTION

beauty concepts ANTIBACTERIAL HAND WIPES Honey Almond

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzalkonium Chloride 0.1%

OTC - PURPOSE SECTION

Purpose:

Antibacterial

INDICATIONS & USAGE SECTION

Uses:

■ To decrease bacteria on hands

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water

Stop use and ask a doctor if irritation or rash occurs. This may be signs of a serious condition

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 at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children two years and over

Peel over reusable label and remove a wipe from the packet.

Wet hands thoroughly and air dry.

Place used wipes into waste basket. Do not flush.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

beauty concepts ANTIBACTERIAL HAND WIPES Sugar Berry

SPL UNCLASSIFIED SECTION

beauty concepts ANTIBACTERIAL HAND WIPES Sugar Berry

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

■ To decrease bacteria on hands

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water

Stop use and ask a doctor if irritation or rash occurs. This may be signs of a serious condition

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 at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children two years and over

Peel over reusable label and remove a wipe from the packet.

Wet hands thoroughly and air dry.

Place used wipes into waste basket. Do not flush.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSN1
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD1
1038856benzalkonium chloride 0.1 % Medicated WipesSY1
1038856benzalkonium chloride 0.1 % Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50563-354-012022-01-28C16284748780-1d6a99b39-63af-a426-e053-dadaa90af4c250563-351/352/353/354 G0XABW01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50563-351-01beauty concepts ANTIBACTERIAL HAND WIPES Coconut Vanilla Honey Almond Sugar Berry20 in 1 PACKETSOLUTION204.5 mg1
50563-352-01beauty concepts ANTIBACTERIAL HAND WIPES Coconut Vanilla Honey Almond Sugar Berry20 in 1 PACKETSOLUTION204.5 mg1
50563-353-01beauty concepts ANTIBACTERIAL HAND WIPES Coconut Vanilla Honey Almond Sugar Berry20 in 1 PACKETSOLUTION204.5 mg1
50563-354-01beauty concepts ANTIBACTERIAL HAND WIPES Coconut Vanilla Honey Almond Sugar Berry1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50563-351BEAUTY CONCEPTS ANTIBACTERIAL HAND WIPES COCONUT VANILLA HONEY ALMOND SUGAR BERRY (BENZALKONIUM CHLORIDE) KIT [ENCHANTE ACCESSORIES INC.]1Unmatched20201021_d83258a3-1fde-48cc-b52e-48dc592d76eb.zip
50563-352BEAUTY CONCEPTS ANTIBACTERIAL HAND WIPES COCONUT VANILLA HONEY ALMOND SUGAR BERRY (BENZALKONIUM CHLORIDE) KIT [ENCHANTE ACCESSORIES INC.]1Unmatched20201021_d83258a3-1fde-48cc-b52e-48dc592d76eb.zip
50563-353BEAUTY CONCEPTS ANTIBACTERIAL HAND WIPES COCONUT VANILLA HONEY ALMOND SUGAR BERRY (BENZALKONIUM CHLORIDE) KIT [ENCHANTE ACCESSORIES INC.]1Unmatched20201021_d83258a3-1fde-48cc-b52e-48dc592d76eb.zip
50563-354BEAUTY CONCEPTS ANTIBACTERIAL HAND WIPES COCONUT VANILLA HONEY ALMOND SUGAR BERRY (BENZALKONIUM CHLORIDE) KIT [ENCHANTE ACCESSORIES INC.]1Legacy NDC, 4 package rows20201021_d83258a3-1fde-48cc-b52e-48dc592d76eb.zip

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
50563-35450563-354-01
50563-35150563-351-01
50563-35250563-352-01
50563-35350563-353-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

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
b221552d-7eb1-4bb6-e053-2a95a90a5e4fd83258a3-1fde-48cc-b52e-48dc592d76eb2020-10-20WarningsExact identifier
spl id: b221552d-7eb1-4bb6-e053-2a95a90a5e4f
spl set id: d83258a3-1fde-48cc-b52e-48dc592d76eb

Reported adverse events (FAERS/openFDA)#

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