FDA.reportPublic FDA data

72476-004- Careone Amber

Manufacturer
Retail Business Services, LLC | Apollo Health and Beauty Care
Effective date
2026-05-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:56:24

Label at a glance#

ProductCareone Amber
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Indications and uses

Helps eliminate bacteria on hands.

Dosage and administration

apply onto wet hands (only for 222 ml and 333 ml) Lather and rinse thoroughly.(For all packages) From a pump bottle, apply onto wet hands (only for 1.66 L bottle) Use to refill a pump bottle (only for 1.66 L bottle)

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.

OTC - STOP USE SECTION

If 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 Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply onto wet hands (only for 222 ml and 333 ml)
  • Lather and rinse thoroughly.(For all packages)
  • From a pump bottle, apply onto wet hands (only for 1.66 L bottle)
  • Use to refill a pump bottle (only for 1.66 L bottle)

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 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).

Questions or comments?

OTC - QUESTIONS SECTION

1-877-846-9949

PDP2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP2PDP2

PDP3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP3PDP3

PDP4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP4PDP4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN5
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD5
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY5
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041520120809GTIN-13: 0041520120809
EAN-13: 0041520120809
GTIN-12: 041520120809
UPC-A: 041520120809
GTIN storage (14 digits): 00041520120809		PDP2.jpg
BarcodeEAN-130041520120847GTIN-13: 0041520120847
EAN-13: 0041520120847
GTIN-12: 041520120847
UPC-A: 041520120847
GTIN storage (14 digits): 00041520120847		PDP4.jpg
BarcodeEAN-130041520147257GTIN-13: 0041520147257
EAN-13: 0041520147257
GTIN-12: 041520147257
UPC-A: 041520147257
GTIN storage (14 digits): 00041520147257		PDP3.jpg

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-004-02Careone Amber222 mL in 1 BOTTLE, PLASTICSOAP2225
72476-004-03Careone Amber333 mL in 1 BOTTLE, PLASTICSOAP3335
72476-004-04Careone Amber1660 mL in 1 BOTTLE, PLASTICSOAP16605

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-00472476-004-02, 72476-004-03, 72476-004-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCO MONOETHANOLAMIDEC80684146DIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM SULFATE0YPR65R21JIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C RED NO. 40WZB9127XOAIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT
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
Careone AmberBENZALKONIUM CHLORIDERetail Business Services, LLCcb8fdf26-8372-70d8-e053-2995a90a840a2026-05-03WarningsExact identifier
ndc (package): 72476-004-03
ndc (package): 72476-004-02
ndc (package): 72476-004-04
ndc (product): 72476-004
ndc11 (package): 72476000404
ndc11 (package): 72476000402
ndc11 (package): 72476000403
spl id: 50eb1e0e-2183-ec8d-e063-6294a90a34f5
spl set id: cb8fdf26-8372-70d8-e053-2995a90a840a

Reported adverse events (FAERS/openFDA)#

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