FDA.reportPublic FDA data

Sani-Sure AF

Manufacturer
Whisk Products, Inc.
Effective date
2024-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:53

Label at a glance#

ProductSani-Sure AF
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin Recommended for repeated use

Dosage and administration

Pump a small amount of foam into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Pump a small amount of foam into palm of hand.
  • Rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly until dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Phenoxyethanol, Lauramine Oxide, Panthenol, Fragrance, Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Case Label - 4 x 1000 mL BagsCase Label - 4 x 1000 mL Bags

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN1
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD1
1038799benzalkonium chloride 0.1 % Topical FoamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-360-01Sani-Sure AF4 in 1 BAGSOLUTION41
65585-360-01Sani-Sure AF1000 mL in 1 BAGSOLUTION10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-360SANI-SURE AF (BENZALKONIUM CHLORIDE) SOLUTION [WHISK PRODUCTS, INC.]1Current NDC, 2 package rows20240906_215edd45-6266-0bfe-e063-6294a90ae9ea.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
65585-36065585-360-01

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
Sani-Sure AFBENZALKONIUM CHLORIDEWhisk Products, Inc.215edd45-6266-0bfe-e063-6294a90ae9ea2024-09-05WarningsExact identifier
ndc (package): 65585-360-01
ndc (product): 65585-360
ndc11 (package): 65585036001
spl id: 215edd0e-bebd-1ffb-e063-6294a90a12a9
spl set id: 215edd45-6266-0bfe-e063-6294a90ae9ea

Reported adverse events (FAERS/openFDA)#

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