FDA.reportPublic FDA data

ANTISEPTIC WIPES

Manufacturer
Zhejiang Jiayan Daily Commodity Co., Ltd
Effective date
2022-02-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:31

Label at a glance#

ProductANTISEPTIC WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

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

Storage and handling

store between 15-30C (59-86F) Avoid freezing and exessive heat aboce 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Decreases bacteria on the skin

Warnings

WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN . FOR EXTERNAL USE ONLY . KEEP OUT OF EYES AND MOUTH . STOP USE IF YOU FEEL UNWELL OR IRRITATED

Do not use

OTC - DO NOT USE SECTION

in childr&n 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a sefious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach o1 children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Open package. Pull wipe. Close package to retain 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 exessive heat aboce 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetylpyrdinium chloride, Propylene Glycol, 2-phenoxyethanol, Disodium EDTA., Citric Acid, Fragrance, Aloe Barbadensis Leaf Juice, Water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

42003-208-02 100P42003-208-02 100P42003-208-01 50P42003-208-01 50P

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
42003-208-012023-07-28C16284748780-1d6a99b3a-005a-a426-e053-dadaa90af4c242003-208 ANTISEPTIC WIPES
42003-208-022023-07-28C16284748780-1d6a99b3a-005a-a426-e053-dadaa90af4c242003-208 ANTISEPTIC WIPES
42003-208-012022-02-25C16284748780-1d6a99b3a-005a-a426-e053-dadaa90af4c242003-208 ANTISEPTIC WIPES
42003-208-022022-02-25C16284748780-1d6a99b3a-005a-a426-e053-dadaa90af4c242003-208 ANTISEPTIC WIPES
42003-208-012022-01-28C16284748780-1d6a99b3a-005a-a426-e053-dadaa90af4c242003-208 ANTISEPTIC WIPES
42003-208-022022-01-28C16284748780-1d6a99b3a-005a-a426-e053-dadaa90af4c242003-208 ANTISEPTIC WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42003-208-01ANTISEPTIC WIPES50 in 1 BAGCLOTH502
42003-208-02ANTISEPTIC WIPES100 in 1 BAGCLOTH1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42003-208ANTISEPTIC WIPES (SANITIZING WIPES) CLOTH [ZHEJIANG JIAYAN DAILY COMMODITY CO., LTD]2Legacy NDC, 2 package rows20220226_b5741e4f-5c14-859e-e053-2995a90a1aa9.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42003-20842003-208-01, 42003-208-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT
LEMON24RS0A988OIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
CHAMOMILEFGL3685T2XIACT

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
d8d3d806-3309-70dd-e053-2a95a90aad00b5741e4f-5c14-859e-e053-2995a90a1aa92022-02-25WarningsExact identifier
spl id: d8d3d806-3309-70dd-e053-2a95a90aad00
spl set id: b5741e4f-5c14-859e-e053-2995a90a1aa9

Reported adverse events (FAERS/openFDA)#

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