FDA.reportPublic FDA data

Antibacterial Hand Wipes

Manufacturer
Orange (Fujian) Sanitary Products Co., Ltd.
Effective date
2021-02-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:25

Label at a glance#

ProductAntibacterial Hand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. 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

BENZALKONIUM CHLORIDE 0.15% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Antibacterial Hand Wipes

Use

INDICATIONS & USAGE SECTION

USES:Single use wipes to cleanse hands and help prevent the spread of bacteria.

Warnings

WARNINGS SECTION

  • For external use only.
  • Do not replace wipes used for medical procedures.
  • These wipes are meant for general cleansing.
  • Flammable. Keep away fire or sources of heat.
  • Avoid contact with eyes.
  • If eyes contact occurs, flush eyes with water.
  • Store at room temperature 59 ℉（15℃）-86 ℉（30℃）.

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

If irritation and redness develop. If condition continues, consult your health care practitoner.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • 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,ALOE EXTRACT,SODIUM PHENYLKALATE

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 cloth NDC: 81614-015-20

20 cloth label20 cloth label

50 cloth NDC: 81614-015-50

50 CLOTH LABEL50 CLOTH LABEL

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
81614-015-202025-01-30C16284748780-12cef2736-607d-d83d-e063-dadaa90ab31f81614-015-20 81614-015-50 Antibacterial Hand Wipes Benzalkonium Chloride
81614-015-502025-01-30C16284748780-12cef2736-607d-d83d-e063-dadaa90ab31f81614-015-20 81614-015-50 Antibacterial Hand Wipes Benzalkonium Chloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81614-015-20Antibacterial Hand Wipes20 in 1 PACKAGECLOTH201
81614-015-20Antibacterial Hand Wipes5.75 g in 1 PATCHCLOTH5.751
81614-015-50Antibacterial Hand Wipes50 in 1 PACKAGECLOTH501
81614-015-50Antibacterial Hand Wipes6 g in 1 PATCHCLOTH61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81614-015ANTIBACTERIAL HAND WIPES (BENZALKONIUM CHLORIDE) CLOTH [ORANGE (FUJIAN) SANITARY PRODUCTS CO., LTD.]1Legacy NDC, 4 package rows20210223_bbbb93d9-218f-3f83-e053-2995a90afde7.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81614-01581614-015-20, 81614-015-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
SODIUM PHENYLLACTATEKYI2U2BS89IACT
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
bbbb933e-34a9-143a-e053-2995a90a7c91bbbb93d9-218f-3f83-e053-2995a90afde72021-02-19WarningsExact identifier
spl id: bbbb933e-34a9-143a-e053-2995a90a7c91
spl set id: bbbb93d9-218f-3f83-e053-2995a90afde7

Reported adverse events (FAERS/openFDA)#

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