FDA.reportPublic FDA data

GERMISEPT Antibacterial Hand Sanitizing Wipes

Manufacturer
Innovent Inc. | American Hygienics Corporation
Effective date
2023-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:41:52

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 resealable label, remove one wipe to use. • Wipe hands thoroughly with product and allow to dry without wiping. • Close resealable label after use to retain moisture.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkhonium Chloride 0.12%

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.

Discontinue use if

SPL UNCLASSIFIED SECTION

irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

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 resealable label, remove one wipe to use.

• Wipe hands thoroughly with product and allow to dry without wiping.

• Close resealable label after use to retain moisture.

Other information

SPL UNCLASSIFIED SECTION

• Store below 95° F (35° C) to prevent from drying out.

• Dispose of wipe in the proper container.

• Do not flush down the toilet.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Purified & De-Ionized Water), Aloe Barbadensis Leaf Extract, Citric Acid, Didecyldimonium Chloride, 2-Bromo-2-Nitropropane-1,3-Diol, Polyaminopropyl Biguanide, Parfum (Fragrance).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70335-301GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES (BENZALKONIUM CHLORIDE) LIQUID [INNOVENT INC.]2Legacy NDC20230105_47c19c9d-69a0-4375-b882-74301f00b317.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70335-30170335-301-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CHAMOMILEFGL3685T2XIACT
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
f15ea0dc-53e3-6360-e053-2a95a90ae30447c19c9d-69a0-4375-b882-74301f00b3172023-01-03WarningsExact identifier
spl id: f15ea0dc-53e3-6360-e053-2a95a90ae304
spl set id: 47c19c9d-69a0-4375-b882-74301f00b317

Reported adverse events (FAERS/openFDA)#

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