FDA.reportPublic FDA data

Careone Amber Antibacterial Hand

Manufacturer
American Sales Company | Apollo Health and Beauty Care Inc.
Effective date
2018-02-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:37

Label at a glance#

ProductCareone Amber Antibacterial Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

helps eliminate bacteria on hands.

Dosage and administration

apply onto wet hands lather and rinse thoroughly

Storage and handling

store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

helps eliminate bacteria on hands.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or redness develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply onto wet hands
  • lather and rinse thoroughly

Other information

STORAGE AND HANDLING SECTION

store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19040), Red 33 (CI 17200).

Questions or comments?

OTC - QUESTIONS SECTION

1-877-846-9949

Label copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of the labelimage of the 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-320-072024-01-30C16284748780-11030e365-42fd-111a-e063-dadaa90a10e2Drug Facts
41520-320-562024-01-30C16284748780-11030e365-42fd-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-320-07Careone Amber Antibacterial Hand222 mL in 1 BOTTLE, PLASTICSOAP2221
41520-320-56Careone Amber Antibacterial Hand1656 mL in 1 BOTTLE, PLASTICSOAP16561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-320CAREONE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [AMERICAN SALES COMPANY]1Legacy NDC, 2 package rows20180216_fef3ca7a-59ed-4748-9d49-fb2a7e7fda9d.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-32041520-320-56, 41520-320-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
GLYCERINPDC6A3C0OXIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
SODIUM CHLORIDE451W47IQ8XIACT
COCO MONOETHANOLAMIDEC80684146DIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM SULFATE0YPR65R21JIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT

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
ebd0fa9a-1495-4550-9c4a-e7da972146befef3ca7a-59ed-4748-9d49-fb2a7e7fda9d2018-02-15WarningsExact identifier
spl id: ebd0fa9a-1495-4550-9c4a-e7da972146be
spl set id: fef3ca7a-59ed-4748-9d49-fb2a7e7fda9d

Reported adverse events (FAERS/openFDA)#

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