FDA.reportPublic FDA data

Antibacterial Wipes

Manufacturer
Orazen Inc | Zhegiang Qimei Commodity Co/ Ltd
Effective date
2020-05-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:30

Label at a glance#

ProductAntibacterial Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Apply to hands allow skin to dry without wiping Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Packaging ArtworkPackaging ArtworkBenzalkonium Chloride 0.13 % v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antibacterial, Wipe

Use

INDICATIONS & USAGE SECTION

Decrease bacteria on skin. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. 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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply to hands
  • allow skin to dry without wiping
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ct NDC: 69821-001-25 Package Label PrincipalPackage Label Principal

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
71927-010-012022-01-28C16284748780-1d6a99b39-3e93-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-010-01Antibacterial Wipes0.1 mL in 1 POUCHSWAB0.11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-010ANTIBACTERIAL WIPES (BENZALKONIUM CHLORIDE) SWAB [ORAZEN INC]1Legacy NDC, 1 package rows20200525_a609ec7f-bfe9-2d81-e053-2a95a90a0ca6.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71927-01071927-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
POLYSORBATE 207T1F30V5YHIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT

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
a609ec7f-bfea-2d81-e053-2a95a90a0ca6a609ec7f-bfe9-2d81-e053-2a95a90a0ca62020-05-18WarningsExact identifier
spl id: a609ec7f-bfea-2d81-e053-2a95a90a0ca6
spl set id: a609ec7f-bfe9-2d81-e053-2a95a90a0ca6

Reported adverse events (FAERS/openFDA)#

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