FDA.reportPublic FDA data

Careone Amber

Manufacturer
Spa Dent Inc | Apollo Health and Beauty Care
Effective date
2021-07-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:39:48

Label at a glance#

ProductCareone Amber
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 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.

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

PDP2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP2PDP2

PDP3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP3PDP3

PDP4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP4PDP4

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
79147-01879147-018-02, 79147-018-03, 79147-018-04

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
GLYCERINPDC6A3C0OXIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
SODIUM CHLORIDE451W47IQ8XIACT
COCO MONOETHANOLAMIDEC80684146DIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM SULFATE0YPR65R21JIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
fd&c red no. 40WZB9127XOAIACT
BASIC YELLOW 507BP340B4TIACT
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
188b0ab9-76b9-4d1f-a476-ca04fe2c5eaa0dcceba3-2685-4fa0-a3b5-50e7f7fb029e2021-07-22WarningsExact identifier
spl id: 188b0ab9-76b9-4d1f-a476-ca04fe2c5eaa
spl set id: 0dcceba3-2685-4fa0-a3b5-50e7f7fb029e

Reported adverse events (FAERS/openFDA)#

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