FDA.reportPublic FDA data

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES CRANBERRY SCENTED

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 23:32:04

Label at a glance#

ProductBODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES CRANBERRY SCENTED
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

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 in to waste basket.  Do not flush.

Label contents#

Full prescribing information#

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 eyes thoroughly with water

Stop use and ask a doctor if irritation or rash occurs. These 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 in to waste basket.  Do not flush.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50563-369-012022-01-28C16284748780-1d6a99b39-7d92-a426-e053-dadaa90af4c250563-369_G0XABW07

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50563-369-01BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES CRANBERRY SCENTED100 in 1 PACKETSOLUTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50563-369BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES CRANBERRY SCENTED (BENZALKONIUM CHLORIDE) SOLUTION [ENCHANTE ACCESSORIES INC.]1Legacy NDC, 1 package rows20201021_685ee531-2d7b-4ee1-a0e3-ec0c2d2af9ab.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50563-36950563-369-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
VACCINIUM MACROCARPON WHOLED11KO7O2DXIACT
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
b2215c45-01d5-0832-e053-2995a90aa6d2685ee531-2d7b-4ee1-a0e3-ec0c2d2af9ab2020-10-20WarningsExact identifier
spl id: b2215c45-01d5-0832-e053-2995a90aa6d2
spl set id: 685ee531-2d7b-4ee1-a0e3-ec0c2d2af9ab

Reported adverse events (FAERS/openFDA)#

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