FDA.reportPublic FDA data

50563-372/373/374/375 G1ABCW09

Manufacturer
ENCHANTE ACCESSORIES INC. | Zhejiang Ruolin Hygienic Products Co., Ltd.
Effective date
2020-10-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:29

Label at a glance#

ProductBODY PRESCRIPTIONS antibacterial hand wipes juicy peach peach mint strawberry peach
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#

BODY PRESCRIPTIONS antibacterial hand wipes juicy peach

SPL UNCLASSIFIED SECTION

BODY PRESCRIPTIONS antibacterial hand wipes juicy peach

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, Prunus Persica (Peach) Fruit Extract, Water

BODY PRESCRIPTIONS antibacterial hand wipes peach mint

SPL UNCLASSIFIED SECTION

BODY PRESCRIPTIONS antibacterial hand wipes peach mint

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose:

OTC - PURPOSE SECTION

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, Mentha Arvensis Leaf Extract, Phenoxyethanol, Propylene Glycol, Prunus Persica (Peach) Fruit Extract, Water

BODY PRESCRIPTIONS antibacterial hand wipes strawberry peach

SPL UNCLASSIFIED SECTION

BODY PRESCRIPTIONS antibacterial hand wipes strawberry peach

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, Fragaria Chiloensis (Strawberry) Fruit Extract, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Prunus Persica (Peach) Fruit Extract, 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
50563-375-012022-01-28C16284748780-1d6a99b39-4a33-a426-e053-dadaa90af4c250563-372/373/374/375 G1ABCW09

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50563-372-01BODY PRESCRIPTIONS antibacterial hand wipes juicy peach peach mint strawberry peach20 in 1 PACKETSOLUTION204.5 mg1
50563-373-01BODY PRESCRIPTIONS antibacterial hand wipes juicy peach peach mint strawberry peach20 in 1 PACKETSOLUTION204.5 mg1
50563-374-01BODY PRESCRIPTIONS antibacterial hand wipes juicy peach peach mint strawberry peach20 in 1 PACKETSOLUTION204.5 mg1
50563-375-01BODY PRESCRIPTIONS antibacterial hand wipes juicy peach peach mint strawberry peach1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50563-372BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES JUICY PEACH PEACH MINT STRAWBERRY PEACH (BENZALKONIUM CHLORIDE) KIT [ENCHANTE ACCESSORIES INC.]1Unmatched20201028_6d6718b9-fbb6-409a-8b0f-db9e76baa377.zip
50563-373BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES JUICY PEACH PEACH MINT STRAWBERRY PEACH (BENZALKONIUM CHLORIDE) KIT [ENCHANTE ACCESSORIES INC.]1Unmatched20201028_6d6718b9-fbb6-409a-8b0f-db9e76baa377.zip
50563-374BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES JUICY PEACH PEACH MINT STRAWBERRY PEACH (BENZALKONIUM CHLORIDE) KIT [ENCHANTE ACCESSORIES INC.]1Unmatched20201028_6d6718b9-fbb6-409a-8b0f-db9e76baa377.zip
50563-375BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES JUICY PEACH PEACH MINT STRAWBERRY PEACH (BENZALKONIUM CHLORIDE) KIT [ENCHANTE ACCESSORIES INC.]1Legacy NDC, 4 package rows20201028_6d6718b9-fbb6-409a-8b0f-db9e76baa377.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50563-37550563-375-01
50563-37250563-372-01
50563-37350563-373-01
50563-37450563-374-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
PEACH JUICEK37IH01KN1IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
PEACH JUICEK37IH01KN1IACT
MENTHA ARVENSIS LEAFA4IWO4DDZ9IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
PEACH JUICEK37IH01KN1IACT
STRAWBERRY JUICEU8NS58UGW0IACT
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
b2b085f0-1e12-0bab-e053-2995a90a19686d6718b9-fbb6-409a-8b0f-db9e76baa3772020-10-27WarningsExact identifier
spl id: b2b085f0-1e12-0bab-e053-2995a90a1968
spl set id: 6d6718b9-fbb6-409a-8b0f-db9e76baa377

Reported adverse events (FAERS/openFDA)#

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