FDA.reportPublic FDA data

TOPSANI

Manufacturer
Prime Enterprises
Effective date
2022-04-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:04:19

Label at a glance#

ProductTOPSANI
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.​

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.125%​

Purpose

OTC - PURPOSE SECTION

Antomicrobial

Indications

INDICATIONS & USAGE SECTION

For Handwashing to decrease bacteria

Warning

WARNINGS SECTION

For external use only.

When using this product avoid contact with the eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

Directions

INSTRUCTIONS FOR USE SECTION

Wet hands thoroughly with product and allow to dry without wiping.​

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Blue 1, Fragrance, Hydroxypropyl Methylcellulose, Polysorbate 20, SD Alcohol 40-B, Urea, Water ​

Questions or comments

OTC - QUESTIONS SECTION

Call 1-877-541-6055​

Keep out of reach of children

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.​

Instructions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping.​

Principal Display Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

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
58443-033558443-0335-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
UREA8W8T17847WIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALCOHOL3K9958V90MIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
WATER059QF0KO0RIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
POLYSORBATE 207T1F30V5YHIACT

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
dbea1faf-5c40-6ddd-e053-2a95a90ad545a6a4700d-f844-1229-e053-2995a90a4c7e2022-04-05WarningsExact identifier
spl id: dbea1faf-5c40-6ddd-e053-2a95a90ad545
spl set id: a6a4700d-f844-1229-e053-2995a90a4c7e

Reported adverse events (FAERS/openFDA)#

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