FDA.reportPublic FDA data

Sanitizing Wipes

Manufacturer
Zhejiang Fanjia Medical Equipment Co., Ltd.
Effective date
2021-01-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:36:36

Label at a glance#

ProductSanitizing Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

Suitable for skin cleaning and sterilization

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping

Storage and handling

Do not store above 110F May discolor some fabrics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua,Isopropyl alcohol, Propylene glycol, Tocopherol acetate, polysorbote 20, phenoxyethanol, Perfume

Uses

INDICATIONS & USAGE SECTION

Suitable for skin cleaning and sterilization

Warnings

WARNINGS SECTION

For external use only.

Flammable,keep away from fire or flame

Do not use

OTC - DO NOT USE SECTION

  • on open skin wounds

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes.In case of contact with eyes, rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develop.

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

  • Wet hands thoroughly with product and allow to dry without wiping

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 110F
  • May discolor some fabrics

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

160PCS NDC 80991-003-04 003-04003-04

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80991-003-042022-07-29C16284748780-1e4f33bdf-a7f6-d8a0-e053-dadaa90a6e4e0.13ben fanjia

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80991-003-04Sanitizing Wipes5 g in 1 APPLICATORCLOTH55
80991-003-04Sanitizing Wipes160 in 1 CANISTERCLOTH1605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80991-003SANITIZING WIPES (BENZALKONIUM CHLORIDE) CLOTH [ZHEJIANG FANJIA MEDICAL EQUIPMENT CO., LTD.]5Legacy NDC, 2 package rows20210108_b32f773e-f8fb-3739-e053-2a95a90a7b45.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
80991-00380991-003-04

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
POLYSORBATE 207T1F30V5YHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ISOPROPYL ALCOHOLND2M416302IACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
WATER059QF0KO0RIACT
FAGRAEA BERTEROANA FLOWER OIL6665W245VPIACT
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
b84674ad-f16b-1a69-e053-2a95a90a2cafb32f773e-f8fb-3739-e053-2a95a90a7b452021-01-06WarningsExact identifier
spl id: b84674ad-f16b-1a69-e053-2a95a90a2caf
spl set id: b32f773e-f8fb-3739-e053-2a95a90a7b45

Reported adverse events (FAERS/openFDA)#

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