FDA.reportPublic FDA data

GERMisept Antibacterial Hand Sanitizing Wipes

Manufacturer
Innovent Inc
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:25

Label at a glance#

ProductGERMisept Antibacterial Hand Sanitizing Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

Decrease bacteria on the skin.

Dosage and administration

Open the flip top lid, remove one wipe to use. Wipe hands thoroughly the product and allow to dry without wiping. Close flip top lid after use to retain moisture.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses:

INDICATIONS & USAGE SECTION

Decrease bacteria on the skin.

Warnings

WARNINGS SECTION

  • For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Do not use

OTC - DO NOT USE SECTION

if irritation and redness develop.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if condition persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Open the flip top lid, remove one wipe to use.
  • Wipe hands thoroughly the product and allow to dry without wiping.
  • Close flip top lid after use to retain moisture.

Other information

SPL UNCLASSIFIED SECTION

  • Dispose of wipe in the proper container.
  • Do not flush down the toilet.

*Kill Claims Against: E.Coli & Staphylococcus.

Inactive ingredients

INACTIVE INGREDIENT SECTION

2-Bromo-2-Nitropropane-1,3-Diol, Alcohol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Citric Acid, Fragrance, Iodopropynyl Butylcarbamate, Lauryl Glucoside, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Water.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bag3Bag3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSN3
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD3
1038856benzalkonium chloride 0.1 % Medicated WipesSY3
1038856benzalkonium chloride 0.1 % Topical SwabSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70335-012-01GERMisept Antibacterial Hand Sanitizing Wipes4 in 1 BAGCLOTH43
70335-012-01GERMisept Antibacterial Hand Sanitizing Wipes50 in 1 PACKAGECLOTH503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70335-012GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES (BENZALKONIUM CHLORIDE) CLOTH [INNOVENT INC]3Current NDC, Legacy NDC, 2 package rows20231222_ba4a04dc-7740-bd1b-e053-2995a90a089c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70335-01270335-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BRONOPOL6PU1E16C9WIACT
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE SODIUMMP1J8420LUIACT
WATER059QF0KO0RIACT
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
GERMisept Antibacterial Hand Sanitizing WipesBENZALKONIUM CHLORIDEInnovent Incba4a04dc-7740-bd1b-e053-2995a90a089c2023-12-21WarningsExact identifier
ndc (package): 70335-012-01
ndc (product): 70335-012
ndc11 (package): 70335001201
spl id: 0d0d5824-168c-a063-e063-6294a90aa025
spl set id: ba4a04dc-7740-bd1b-e053-2995a90a089c

Reported adverse events (FAERS/openFDA)#

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