FDA.reportPublic FDA data

SANITARY WET WIPES

Manufacturer
Dandong Xinshidai Biotec Pharmaceuticals Co.,LTD
Effective date
2020-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:35:57

Label at a glance#

ProductSANITARY WET WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Indications and uses

Suitable for wiping hands, face, skin and other unbroken skin.

Dosage and administration

Take out the wet wipes and use directly

Storage and handling

· Store in a cool place, avoid sunlight or high temperature. · Shelf Life: 2 years · Product specification: 160mm × 200mm · Product features: pure cotton texture, soft and comfortable It has bactericidal effect on Staphylococcus aureus, Escherichia coli and Candida albicans. · See the code on the package for the expiration date and production lot number

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Suitable for wiping hands, face, skin and other unbroken skin.

Warnings

WARNINGS SECTION

For external use only.

When using this product avoid to contact eyes, wounds and other sensitive parts. 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.

This product is insoluble in water, please put it in the trash after use.

OTC - WHEN USING SECTION

When using this product avoid to contact eyes, wounds and other sensitive parts. 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 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

Take out the wet wipes and use directly

Other Information

STORAGE AND HANDLING SECTION

· Store in a cool place, avoid sunlight or high temperature.

· Shelf Life: 2 years

· Product specification: 160mm × 200mm

· Product features: pure cotton texture, soft and comfortable

It has bactericidal effect on Staphylococcus aureus, Escherichia coli and Candida albicans.

· See the code on the package for the expiration date and production lot number

Inactive Ingredients

INACTIVE INGREDIENT SECTION

RO water, Bronopol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Net Contents: 1 PCS; NDC: 81306-001-01

1pcs label1pcs label

Net Contents: 10PCS; NDC: 81306-001-02

10pcs label10pcs label

Net Contents: 60PCS; NDC: 81306-001-03

60pcs label60pcs label

Net Contents: 72PCS; NDC: 81306-001-04

72pcs label72pcs label

Net Contents: 80PCS; NDC: 81306-001-05

80pcs label80pcs label

Net Contents: 100PCS; NDC: 81306-001-06

100pcs label100pcs label

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
81306-001-012022-01-28C16284748780-1d6a99b39-67b1-a426-e053-dadaa90af4c2SANITARY WET WIPES
81306-001-022022-01-28C16284748780-1d6a99b39-67b1-a426-e053-dadaa90af4c2SANITARY WET WIPES
81306-001-032022-01-28C16284748780-1d6a99b39-67b1-a426-e053-dadaa90af4c2SANITARY WET WIPES
81306-001-042022-01-28C16284748780-1d6a99b39-67b1-a426-e053-dadaa90af4c2SANITARY WET WIPES
81306-001-052022-01-28C16284748780-1d6a99b39-67b1-a426-e053-dadaa90af4c2SANITARY WET WIPES
81306-001-062022-01-28C16284748780-1d6a99b39-67b1-a426-e053-dadaa90af4c2SANITARY WET WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81306-001-01SANITARY WET WIPES5.5 g in 1 PATCHCLOTH5.52
81306-001-01SANITARY WET WIPES1 in 1 BAGCLOTH12
81306-001-02SANITARY WET WIPES10 in 1 BAGCLOTH102
81306-001-02SANITARY WET WIPES5.5 g in 1 PATCHCLOTH5.52
81306-001-03SANITARY WET WIPES5.5 g in 1 PATCHCLOTH5.52
81306-001-03SANITARY WET WIPES60 in 1 BAGCLOTH602
81306-001-04SANITARY WET WIPES5.5 g in 1 PATCHCLOTH5.52
81306-001-04SANITARY WET WIPES72 in 1 BAGCLOTH722
81306-001-05SANITARY WET WIPES5.5 g in 1 PATCHCLOTH5.52
81306-001-05SANITARY WET WIPES80 in 1 BAGCLOTH802
81306-001-06SANITARY WET WIPES100 in 1 BAGCLOTH1002
81306-001-06SANITARY WET WIPES5.5 g in 1 PATCHCLOTH5.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81306-001SANITARY WET WIPES CLOTH [DANDONG XINSHIDAI BIOTEC PHARMACEUTICALS CO.,LTD]2Legacy NDC, 12 package rows20201228_b716cb7d-d46c-caaa-e053-2a95a90aac7c.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81306-00181306-001-01, 81306-001-02, 81306-001-03, 81306-001-04, 81306-001-05, 81306-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
BRONOPOL6PU1E16C9WIACT

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
b77d5463-f079-b694-e053-2a95a90a0dbbb716cb7d-d46c-caaa-e053-2a95a90aac7c2020-12-27WarningsExact identifier
spl id: b77d5463-f079-b694-e053-2a95a90a0dbb
spl set id: b716cb7d-d46c-caaa-e053-2a95a90aac7c

Reported adverse events (FAERS/openFDA)#

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