FDA.reportPublic FDA data

Antibacterial Aqua Clear

Manufacturer
Sante Manufacturing Inc
Effective date
2025-01-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:51:14

Label at a glance#

ProductAntibacterial Aqua Clear 2X Ultra
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride - 0.13%

OTC - PURPOSE SECTION

Purpose: Antibacterial

DOSAGE & ADMINISTRATION SECTION

Direction

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse

WARNINGS SECTION

For external use only

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops

OTC - WHEN USING SECTION

When using this product

  • do not get it into eyes. If contact occurs, rinse eye thoroughly with water

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

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, Red# 4 (Cl 14700)

INDICATIONS & USAGE SECTION

Uses for handwashing or decrease bacteria to the skin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN3
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY3
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71020-030-30Antibacterial Aqua Clear2X Ultra600 mL in 1 BOTTLE, PLASTICLIQUID6003
71020-030-64Antibacterial Aqua Clear2X Ultra1900 mL in 1 BOTTLE, PLASTICLIQUID19003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71020-030ANTIBACTERIAL AQUA CLEAR 2X ULTRA (BENZALKONIUM CHLORIDE) LIQUID [SANTE MANUFACTURING INC]3Current NDC, Legacy NDC, 2 package rows20250109_d5d15729-1dc1-2b44-e053-2a95a90a26c5.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
71020-03071020-030-64, 71020-030-30

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 4X3W0AM1JLXIACT
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
Antibacterial Aqua Clear 2X UltraBENZALKONIUM CHLORIDESante Manufacturing Incd5d15729-1dc1-2b44-e053-2a95a90a26c52025-01-07WarningsExact identifier
ndc (package): 71020-030-30
ndc (package): 71020-030-64
ndc (product): 71020-030
ndc11 (package): 71020003064
ndc11 (package): 71020003030
spl id: 2b21995e-29b7-a54c-e063-6394a90aa3e7
spl set id: d5d15729-1dc1-2b44-e053-2a95a90a26c5

Reported adverse events (FAERS/openFDA)#

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