FDA.reportPublic FDA data

antiseptic wipes

Manufacturer
Shandong Liaocheng Chaoyue Daily Necessities Co., Ltd.
Effective date
2021-02-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:49

Label at a glance#

Productantiseptic wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Open package. Pull wipe. Close package to remain moisture Wet hands thoroughly with product. Allow to dry without rinsing

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. BENZALKONIUM CHLORIDE (0.13% v/v).
  2. CETYLPYRIDINIUM CHLORIDE(0.02% v/v).
  3. PROPYLENE GLYCOL(0.1% v/v).
  4. PHENOXYETHANOL(0.02% v/v).
  5. EDETATE DISODIUM(0.001% v/v).
  6. ANHYDROUS CITRIC ACID(0.001% v/v).
  7. ALOE VERA LEAF(0.01% v/v).
  8. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

BENZALKONIUM CHLORIDE 0.13% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Decreases bacteria on the skin

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

  • Open package. Pull wipe. Close package to remain moisture
  • Wet hands thoroughly with product. Allow to dry without rinsing

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

CETYLPYRIDINIUM CHLORIDE(0.02% v/v).
PROPYLENE GLYCOL(0.1% v/v).
PHENOXYETHANOL(0.02% v/v).
EDETATE DISODIUM(0.001% v/v).
ANHYDROUS CITRIC ACID(0.001% v/v).
ALOE VERA LEAF(0.01% v/v).
FRAGRANCE
WATER

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77412-012-01 77412-012-0177412-012-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77412-012-012023-01-30C16284748780-1f386c649-d5dc-0266-e053-dadaa90a7c1asanitizing antiseptic wipes
77412-012-022023-01-30C16284748780-1f386c649-d5dc-0266-e053-dadaa90a7c1asanitizing antiseptic wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77412-012-01antiseptic wipes100 in 1 PACKAGECLOTH1002
77412-012-02antiseptic wipes10 in 1 PACKAGECLOTH102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77412-012ANTISEPTIC WIPES (BENZALKONIUM CHLORIDE) CLOTH [SHANDONG LIAOCHENG CHAOYUE DAILY NECESSITIES CO., LTD.]2Legacy NDC, 2 package rows20210206_aff86385-948d-7067-e053-2995a90a298a.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
77412-01277412-012-01, 77412-012-02

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CETYLPYRIDINIUM CHLORIDE ANHYDROUS6BR7T22E2SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT

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
ba920d24-cd15-52be-e053-2995a90a38ccaff86385-948d-7067-e053-2995a90a298a2021-02-05WarningsExact identifier
spl id: ba920d24-cd15-52be-e053-2995a90a38cc
spl set id: aff86385-948d-7067-e053-2995a90a298a

Reported adverse events (FAERS/openFDA)#

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