FDA.reportPublic FDA data

ANTIBACTERIAL Hand

Manufacturer
CROSS BORDER MANUFACTURERS INC. | Absara Cosmetics SAPI de CV
Effective date
2020-09-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:57

Label at a glance#

ProductANTIBACTERIAL Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

For washing to decrease bacteria on the skin.

Dosage and administration

Wet hands with water, apply soap and rub for 20 seconds and rinse.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

For washing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes.
  • In case of eye contact, flush with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop.

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

Wet hands with water, apply soap and rub for 20 seconds and rinse.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, glycerin, polyquaternium -7, fragance, DMDM hydantoin, iodopropynyl butylcarbamate, butylene glycol, chamomilla recutita extract, aloe barbadensis extract, citral, limonene, citronellol, disodium EDTA, linalool, geraniol, hexyl cinnamal, citric acid, yellow 5 (CI 19140), red 40 (CI 16035), glycol distearate, cocamide MEA, Laureth-10

Questions?

OTC - QUESTIONS SECTION

Email: info@aglamee.com

SPL UNCLASSIFIED SECTION

Distributed by Cross-Border Manufacturers Inc.
Dover, DE, 19901

PRINCIPAL DISPLAY PANEL - 500 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aglameé

ANTIBACTERIAL
hand
soap

FRESH CITRUS
WITH CHAMOMILE +ALOE VERA

ANTIBACTERIAL
FORMULA

500 ML | 16.9 FL.OZ

PRINCIPAL DISPLAY PANEL - 500 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 500 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78939-001-012023-01-30C16284748780-1f386c649-ac00-0266-e053-dadaa90a7c1aANTIBACTERIAL Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78939-001-01ANTIBACTERIAL Hand500 mL in 1 BOTTLE, PLASTICLIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78939-001ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [CROSS BORDER MANUFACTURERS INC.]1Legacy NDC, 1 package rows20200923_f9ee3405-8dfb-4ffe-8e1b-495f8d1438a7.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78939-00178939-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
DMDM HYDANTOINBYR0546TOWIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CITRALT7EU0O9VPPIACT
LIMONENE, (+)-GFD7C86Q1WIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
LINALOOL, (+/-)-D81QY6I88EIACT
GERANIOLL837108USYIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCOL DISTEARATE13W7MDN21WIACT
COCO MONOETHANOLAMIDEC80684146DIACT
LAURETH-10BD7AST04GAIACT

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
74bca929-389f-4da4-988e-c6d2d02233c8f9ee3405-8dfb-4ffe-8e1b-495f8d1438a72020-09-22WarningsExact identifier
spl id: 74bca929-389f-4da4-988e-c6d2d02233c8
spl set id: f9ee3405-8dfb-4ffe-8e1b-495f8d1438a7

Reported adverse events (FAERS/openFDA)#

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