FDA.reportPublic FDA data

GERMISEPT Bran ANTIBACTERIAL MOIST

Manufacturer
Innovent Inc.
Effective date
2023-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:42:01

Label at a glance#

ProductGERMISEPT Bran ANTIBACTERIAL MOIST
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

Benzalkonium Chloride 0.115%

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 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

2-Bromo-2-Nitropropane-1,3-Diol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Citric Acid, Iodopropynyl Butylcarbamate, Lauryl Glucoside, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Citrate, Tetrasodium EDTA, Water.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70335-310GERMISEPT BRAN ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SWAB [INNOVENT INC.]2Legacy NDC20230105_be1b44f5-9157-4a64-b384-b7e22d641d8b.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70335-31070335-310-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BRONOPOL6PU1E16C9WIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE1Q73Q2JULRIACT
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
f15eccca-7e89-69c2-e053-2a95a90a5a04be1b44f5-9157-4a64-b384-b7e22d641d8b2023-01-03WarningsExact identifier
spl id: f15eccca-7e89-69c2-e053-2a95a90a5a04
spl set id: be1b44f5-9157-4a64-b384-b7e22d641d8b

Reported adverse events (FAERS/openFDA)#

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