FDA.reportPublic FDA data

Antibacterial Wipes

Manufacturer
Hangzhou Suncilia Yuehui Biotechnology Co., LTD
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:47

Label at a glance#

ProductAntibacterial Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Indications and uses

To decrease bacteria on the skin that could cause disease 1.Remove the wipe from the center of the canister. 2.The next wipe will come out automatically. 3.Close the lid to keep the wipes moist.

Dosage and administration

allow to dry without wiping for children under 6, use only underadult supervision not recommended for infants

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease

1.Remove the wipe from the center of the canister.
2.The next wipe will come out automatically.
3.Close the lid to keep the wipes moist.

Directions

DOSAGE & ADMINISTRATION SECTION

allow to dry without wiping for children under 6, use only underadult supervision not recommended for infants

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.avoid contact with broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness developcondition persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. lf swallowed, get medical help orcontact a Poison Control Center right away.

Other information

HOW SUPPLIED SECTION

keep containers tightly closed in a dry, cool and well-ventilated place

recommended storage temperature: 32°F to 104°F(0°C to 40°c)

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, fragrance, phenoxyethanol,polysorbate 20, propylene glycol, tocopheryl acetate, water

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Disinfection
Sterilization
No Rinseing

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
92185-001-012022-01-28C16284748780-1d6a99b39-4a99-a426-e053-dadaa90af4c2b443fe7a-4786-29f7-e053-2995a90a5e26

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
92185-001-01Antibacterial Wipes40 in 1 PACKETCLOTH401
92185-001-01Antibacterial Wipes0.3 g in 1 PATCHCLOTH0.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
92185-001ANTIBACTERIAL WIPES (WIPE OUT ANTIBACTERIAL WIPES CAR CUPHOLDER CANISTER) CLOTH [HANGZHOU SUNCILIA YUEHUI BIOTECHNOLOGY CO., LTD]1Legacy NDC, 2 package rows20201117_b443fe7a-4786-29f7-e053-2995a90a5e26.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
92185-00192185-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
b443fe7a-4787-29f7-e053-2995a90a5e26b443fe7a-4786-29f7-e053-2995a90a5e262020-11-16WarningsExact identifier
spl id: b443fe7a-4787-29f7-e053-2995a90a5e26
spl set id: b443fe7a-4786-29f7-e053-2995a90a5e26

Reported adverse events (FAERS/openFDA)#

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