FDA.reportPublic FDA data

Antiseptic Wipes

Manufacturer
NAISEN KELIN INDUSTRY CO., LTD
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:17:41

Label at a glance#

ProductAntiseptic Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Discard after a single use and do not flush in the toilet.

Storage and handling

Do not apply internally. Store in a cool dry place below 30˚C

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Sanitizing wipes to help reduce bacteria on the skin or surface of object.

Not to be used on therapeutic devices and hospital.

Warnings

WARNINGS SECTION

For external use only. Do not put in mouth and do not touch eyes.

OTC - WHEN USING SECTION

For external use only. Do not put in mouth and do not touch eyes.

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a physician.

Ask a doctor before use if you have deep or puncture wounds, animal bites, serious burns.

Keep out of reach of children unless under adult supervision.

If swallowed, get medical help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children unless under adult supervision.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Discard after a single use and do not flush in the toilet.

Other information

STORAGE AND HANDLING SECTION

Do not apply internally. Store in a cool dry place below 30˚C

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Benzoate, Phenoxyethanol, Polyaminopropyl Biguanide, PEG-40, Hydrogenated Castor Oil, Citric Acid

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front and Back LabelsFront and Back Labels100 Wipes NDC: 81098-002-02

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81098-00281098-002-02

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
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
HYDROGENATED CASTOR OILZF94AP8MEYIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYAMINOPROPYL BIGUANIDEDT9D8Z79ETIACT
SODIUM BENZOATEOJ245FE5EUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYETHYLENE GLYCOL 2000HAF0412YITIACT

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
d7a02f11-0599-a76f-e053-2995a90ad5bdb6f03e31-6b8b-772b-e053-2a95a90a30892022-02-09WarningsExact identifier
spl set id: b6f03e31-6b8b-772b-e053-2a95a90a3089

Reported adverse events (FAERS/openFDA)#

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