FDA.reportPublic FDA data

CareOne

Manufacturer
American Sales Company | Apollo Health and Beauty Care Inc.
Effective date
2017-05-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:53

Label at a glance#

ProductCareOne Country Apple
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

to decrease bacteria on the skin.

Dosage and administration

apply a small amount to your palm and rub hands together briskly until dry. children under 6 years old should be supervised when using this product.

Storage and handling

store at a room temperature below 110°F (43°C)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable. Keep away from source of heat or fire

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse with water.
Stop using this product and ask 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 a small amount to your palm and rub hands together briskly until dry.
  • children under 6 years old should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • store at a room temperature below 110°F (43°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Fragrance (Parfum), Carbomer, Aminomethyl Propanol, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Glycerin, Mannitol, Cellulose, Hydroxypropyl Methylcellulose, Iron Oxides (CI 77491), Red 33 (CI 17200), Red 40 (CI 16035), Yellow 5 (CI 19140).

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
884783ethanol 65 % Topical SolutionPSN1
884783ethanol 0.65 ML/ML Topical SolutionSCD1
884783ethanol 65 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-410-032020-01-31C16284748780-19d75b9d0-82e1-f424-e053-dadaa90a57ce68ba65c6-4ba7-44fe-a443-6ec4bec77414
41520-410-082020-01-31C16284748780-19d75b9d0-82e1-f424-e053-dadaa90a57ce68ba65c6-4ba7-44fe-a443-6ec4bec77414

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-410-03CareOneCountry Apple59 mL in 1 BOTTLE, PLASTICLIQUID591
41520-410-08CareOneCountry Apple259 mL in 1 BOTTLE, PLASTICLIQUID2591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-410CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]1Legacy NDC, 2 package rows20170518_68ba65c6-4ba7-44fe-a443-6ec4bec77414.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
41520-41041520-410-08, 41520-410-03

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER 934Z135WT9208IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
MANNITOL3OWL53L36AIACT
POWDERED CELLULOSESMD1X3XO9MIACT
HYPROMELLOSES3NXW29V3WOIACT
FERRIC OXIDE RED1K09F3G675IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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
b88957ae-1522-4a82-b8ce-c7bfb3f223c568ba65c6-4ba7-44fe-a443-6ec4bec774142017-05-17WarningsExact identifier
spl id: b88957ae-1522-4a82-b8ce-c7bfb3f223c5
spl set id: 68ba65c6-4ba7-44fe-a443-6ec4bec77414

Reported adverse events (FAERS/openFDA)#

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