FDA.reportPublic FDA data

ANTISEPTIC WIPES

Manufacturer
D&A USA, LLC
Effective date
2020-09-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:26

Label at a glance#

ProductANTISEPTIC WIPES
Active ingredientBENZALKONIUM CHLORIDE, ALCOHOL
Label structure12 sections

Indications and uses

For hand washing to decrease bacteria on the skin. Apply topically to the skin to help prevent cross contamination.

Dosage and administration

Open lid, gently pull back resealable label, remove and use wipe as required. Reseal back after use to avoid evaporation of alcohol. Discard after single use. Required dispose of used wipe in trash receptable. Do not flush.

Storage and handling

Store at room temperature, avoid sunlight irradiating.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 15%. Purpose: Antiseptic

Benzalkonium Chloride 0.1%. Purpose: Antiseptic

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

WARNINGS

WARNINGS SECTION

  • For external use only.

DO NOT USE

OTC - DO NOT USE SECTION

on children less than three years old and on skin wounds.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

Keep out of eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin.

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

irritation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Open lid, gently pull back resealable label, remove and use wipe as required.
  • Reseal back after use to avoid evaporation of alcohol.
  • Discard after single use. Required dispose of used wipe in trash receptable.
  • Do not flush.

USES

INDICATIONS & USAGE SECTION

  • For hand washing to decrease bacteria on the skin.
  • Apply topically to the skin to help prevent cross contamination.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at room temperature, avoid sunlight irradiating.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Cetylpyridinium chloride, Chlorphenesin, Biguanide, Propylene glycol

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72 PCS NDC: 80168-001-01

D&A USA

CONTAINS

75% ALCOHOL STOSTE

ANTISEPTIC WIPES

for hand cleaning

72 Wipes

7.87 x 5.51 in (20 x 14 cm)

package labelpackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2396017benzalkonium chloride 0.1 % / ethanol 15 % Medicated PadPSN1
2396017benzalkonium chloride 1 MG/ML / ethanol 0.15 ML/ML Medicated PadSCD1
2396017benzalkonium chloride 0.1 % / ethanol 15 % Medicated PadSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80168-001-012020-09-28C16284748780-1b05f14d2-1d0a-b864-e053-dadaa90a100aaefd6359-c155-4bfa-e053-2a95a90aa78d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80168-001-01ANTISEPTIC WIPES72 in 1 BAGCLOTH721
80168-001-01ANTISEPTIC WIPES320 mL in 1 BAGCLOTH3201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80168-001ANTISEPTIC WIPES (ALCOHOL, BENZALKONIUM CHLORIDE) CLOTH [D&A USA, LLC]1Legacy NDC, 2 package rows20200916_aefd6359-c155-4bfa-e053-2a95a90aa78d.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
80168-00180168-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
BIGUANIDEFB4Q52I9K2IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALCOHOL3K9958V90MACTIB
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
CHLORPHENESINI670DAL4SZIACT
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
aefd54bc-470c-d591-e053-2995a90a08edaefd6359-c155-4bfa-e053-2a95a90aa78d2020-09-13WarningsExact identifier
spl id: aefd54bc-470c-d591-e053-2995a90a08ed
spl set id: aefd6359-c155-4bfa-e053-2a95a90aa78d

Reported adverse events (FAERS/openFDA)#

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