FDA.reportPublic FDA data

AQUACIL

Manufacturer
Biocentris Pharmaceuticals, LLC
Effective date
2021-06-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:45

Label at a glance#

ProductAQUACIL
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium chloride 0.1% (w/w)

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • To help reduce bacteria on the skin that potentially can cause disease.
  • Recommended for repeated use.

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product keep away from eyes. In case of eye contact, flush eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develop 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Pump sufficient amount of foam into palm of hand.
  • Wet all surfaces of both hands thoroughly with product, including the area under the fingernails.
  • Rub hands together until dry.

INACTIVE INGREDIENT SECTION

Inactive ingredients Cetrimonium Chloride, Laurtrimonium Chloride, Phenoxyethanol, Stearalkonium Chloride, Water.

SPL UNCLASSIFIED SECTION

Developed and Marketed by biocentris PHARMACEUTICALS

24 Executive Parkway, Ringwood, NJ 07456

888-497-4373

info@biocentris.com • www.biocentris.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AQUACIL®
FOAMING HAND SANITIZER

Benzalkonium Chloride 0.1%

KILLS 99.9% OF GERMS
Alcohol Free Formula

33.8 fl oz (1000 mL)

Aquacil Instant Foaming HS_BZKAquacil Instant Foaming HS_BZK

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN2
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD2
1038799benzalkonium chloride 0.1 % Topical FoamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81232-170-032023-01-30C16284748780-1f386c649-e35d-0266-e053-dadaa90a7c1aBiocentris Aquacil
81232-170-082023-01-30C16284748780-1f386c649-e35d-0266-e053-dadaa90a7c1aBiocentris Aquacil
81232-170-102023-01-30C16284748780-1f386c649-e35d-0266-e053-dadaa90a7c1aBiocentris Aquacil
81232-170-162023-01-30C16284748780-1f386c649-e35d-0266-e053-dadaa90a7c1aBiocentris Aquacil
81232-170-172023-01-30C16284748780-1f386c649-e35d-0266-e053-dadaa90a7c1aBiocentris Aquacil
81232-170-372023-01-30C16284748780-1f386c649-e35d-0266-e053-dadaa90a7c1aBiocentris Aquacil
81232-170-432023-01-30C16284748780-1f386c649-e35d-0266-e053-dadaa90a7c1aBiocentris Aquacil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81232-170-03AQUACIL50 mL in 1 BOTTLE, PUMPLIQUID502
81232-170-08AQUACIL237 mL in 1 BOTTLE, PUMPLIQUID2372
81232-170-10AQUACIL1000 mL in 1 POUCHLIQUID10002
81232-170-16AQUACIL473 mL in 1 BOTTLE, PLASTICLIQUID4732
81232-170-17AQUACIL532 mL in 1 BOTTLELIQUID5322
81232-170-37AQUACIL3785 mL in 1 BOTTLELIQUID37852
81232-170-43AQUACIL1000 mL in 1 CARTRIDGELIQUID10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81232-170AQUACIL (BENZALKONIUM CHLORIDE) LIQUID [BIOCENTRIS PHARMACEUTICALS, LLC]2Legacy NDC, 7 package rows20210608_b61f0174-528e-2b23-e053-2995a90ac9e6.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81232-17081232-170-03, 81232-170-08, 81232-170-16, 81232-170-37, 81232-170-43, 81232-170-10, 81232-170-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARALKONIUM CHLORIDE0OUO26BB88IACT
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
c42ed664-8bf1-a37a-e053-2995a90af4fab61f0174-528e-2b23-e053-2995a90ac9e62021-06-07WarningsExact identifier
spl id: c42ed664-8bf1-a37a-e053-2995a90af4fa
spl set id: b61f0174-528e-2b23-e053-2995a90ac9e6

Reported adverse events (FAERS/openFDA)#

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