FDA.reportPublic FDA data

Careone

Manufacturer
Retail Business Services, LLC | Apollo Health and Beauty Care | Spa Dent Inc
Effective date
2021-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:15

Label at a glance#

ProductCareone
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), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Citrus Nobilis (Mandarin Orange) Peel Extract, Camellia Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (Cl 19140), Yellow 6 (Cl 15985).

PDP03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP03PDP03

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
72476-003-032023-01-30C16284748780-1f386c649-bacf-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-003-03Careone333 mL in 1 BOTTLE, PLASTICSOAP3331

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-003CAREONE (BENZALKONIUM CHLORIDE) SOAP [RETAIL BUSINESS SERVICES, LLC]1Legacy NDC, 1 package rows20210903_cb062055-51a5-30ab-e053-2995a90a534a.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-00372476-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
BASIC YELLOW 507BP340B4TIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRUS NOBILIS8MFF77J91VIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
COCO MONOETHANOLAMIDEC80684146DIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
ZINGIBER OFFICINALE WHOLEIN6Q3S3414IACT
FRAGRANCE FRESH CITRUS FLORAL ORC1501495OU4GI2R2WBIACT
SODIUM SULFATE0YPR65R21JIACT
DIRECT YELLOW 69CU9YEE7RCIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
EDETATE SODIUMMP1J8420LUIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT

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
cb072cfb-fb11-735e-e053-2a95a90a2867cb062055-51a5-30ab-e053-2995a90a534a2021-09-02WarningsExact identifier
spl id: cb072cfb-fb11-735e-e053-2a95a90a2867
spl set id: cb062055-51a5-30ab-e053-2995a90a534a

Reported adverse events (FAERS/openFDA)#

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