FDA.reportPublic FDA data

WIPE OUT Antibacterial Wipes, Fresh Scent

Manufacturer
Jianerkang Medical Co., Ltd
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:21

Label at a glance#

ProductWIPE OUT Antibacterial Wipes, Fresh Scent
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

To decrease bacteria on the skin that could cause disease

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease

Warnings

WARNINGS SECTION

  • For external use only

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develops
  • condition persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED 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 Ingredients

INACTIVE INGREDIENT SECTION

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

Package Labeling:20 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling:80 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN3
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD3
1038558benzalkonium chloride 0.13 % Topical ClothSY3
1038558benzalkonium chloride 0.13 % Topical SwabSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY3
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-0010-1WIPE OUT Antibacterial Wipes, Fresh Scent4.2 mL in 1 PATCHCLOTH4.23
34645-0010-1WIPE OUT Antibacterial Wipes, Fresh Scent20 in 1 BAGCLOTH203
34645-0010-2WIPE OUT Antibacterial Wipes, Fresh Scent3.525 mL in 1 PATCHCLOTH3.5253
34645-0010-2WIPE OUT Antibacterial Wipes, Fresh Scent80 in 1 BOTTLECLOTH803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0010WIPE OUT ANTIBACTERIAL WIPES, FRESH SCENT (BENZALKONIUM CHLORIDE) CLOTH [JIANERKANG MEDICAL CO., LTD]3Current NDC, Legacy NDC, 4 package rows20231023_afd76301-e165-7098-e053-2995a90a2926.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34645-001034645-0010-1, 34645-0010-2

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
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
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
WIPE OUT Antibacterial Wipes, Fresh ScentBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdafd76301-e165-7098-e053-2995a90a29262023-10-23WarningsExact identifier
ndc (package): 34645-0010-2
ndc (package): 34645-0010-1
ndc (product): 34645-0010
ndc11 (package): 34645001002
ndc11 (package): 34645001001
spl id: 085d20a0-8ca3-0d49-e063-6394a90a97f5
spl set id: afd76301-e165-7098-e053-2995a90a2926

Reported adverse events (FAERS/openFDA)#

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