FDA.reportPublic FDA data

ANTISEPTIC WIPE

Manufacturer
Ashtel Studios Inc.
Effective date
2020-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:34:36

Label at a glance#

ProductANTISEPTIC WIPE
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% v/v

Purpose

Antiseptic

OTC - PURPOSE SECTION

First aid antiseptic to help prevent skin infection in:

  • Minor Cuts
  • Scrapes
  • Burns
  • Antiseptic Cleasing
  • Perineal and maternity care

WARNINGS SECTION

For External Use Only.

OTC - DO NOT USE SECTION

Do not use

  • As an antiseptic for more than 1 week
  • In the eyes
  • Over large areas of the body

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • Deep or pucture wounds
  • Animal bites
  • Serious burns

OTC - STOP USE SECTION

Stop use

  • If irritation and redness develop
  • If condition persists more than 72 hours, consult a physician.

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.

INDICATIONS & USAGE SECTION

Directions

  • Tear at notch
  • Remove towelette
  • Use only once

As a first aid antiseptic

  • Clean affected area
  • Apply 1 to 3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first

OTHER SAFETY INFORMATION

Other information

  • Store at room temperature
  • Avoid excessive heat

INACTIVE INGREDIENT SECTION

Inactive ingredients

  • Water

DOSAGE & ADMINISTRATION SECTION

ANTISEPTIC WIPE

  • 2in x 2.4in / 5cm x 6cm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BZKBZK

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043307benzalkonium Cl 0.133 % Medicated PadPSN4
1043307benzalkonium chloride 1.33 MG/ML Medicated PadSCD4
1043307benzalkonium chloride 0.133 % Medicated ToweletteSY4
1043307benzalkonium chloride 0.133 % Topical SwabSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-100-012024-01-30C16284748780-11030e365-111b-111a-e063-dadaa90a10e2566faaaf-2eef-3d54-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-100-01ANTISEPTIC WIPE1.8 g in 1 POUCHCLOTH1.84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-100ANTISEPTIC WIPE (BENZALKONIUM CHLORIDE) CLOTH [ASHTEL STUDIOS INC.]4Legacy NDC, 1 package rows20201205_566faaaf-2eef-3d54-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-10070108-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT

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
b59d37af-1202-b418-e053-2995a90a3907566faaaf-2eef-3d54-e054-00144ff88e882020-12-03WarningsExact identifier
spl id: b59d37af-1202-b418-e053-2995a90a3907
spl set id: 566faaaf-2eef-3d54-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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