FDA.reportPublic FDA data

Careone Vanilla Buttercream Hand Sanitizer

Manufacturer
American Sales Company | Apollo Health and Beauty Care Inc.
Effective date
2017-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:35

Label at a glance#

ProductCareone Vanilla Buttercream Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

helps reduce bacteria on the skin

Dosage and administration

wet hands thoroughly and rub together until dry.

Storage and handling

store at a 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

  • helps reduce 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 eyes thoroughly with water.
Stop using this product 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

  • wet hands thoroughly and rub together until dry.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Isopropyl Alcohol, Propylene Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum), Red 33 (CI 17200), Yellow 5 (CI 19140).

Label Copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the label 8ozImage of the label 8oz

Image of the label 2 ozImage of the label 2 oz

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-058-022024-01-30C16284748780-11030e365-68ac-111a-e063-dadaa90a10e2Drug Facts
41520-058-082024-01-30C16284748780-11030e365-68ac-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-058-02Careone Vanilla Buttercream Hand Sanitizer59 mL in 1 BOTTLE, PLASTICLIQUID591
41520-058-08Careone Vanilla Buttercream Hand Sanitizer236 mL in 1 BOTTLE, PLASTICLIQUID2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-058CAREONE VANILLA BUTTERCREAM HAND SANITIZER (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]1Legacy NDC, 2 package rows20170928_4982a1bd-a4f4-4db9-9798-9b1e9ae34348.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-05841520-058-08, 41520-058-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
CARBOMER 934Z135WT9208IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
D&C RED NO. 339DBA0SBB0LIACT
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
64b5b6e4-4935-4d8a-8581-dc1240ba16a94982a1bd-a4f4-4db9-9798-9b1e9ae343482017-09-26WarningsExact identifier
spl id: 64b5b6e4-4935-4d8a-8581-dc1240ba16a9
spl set id: 4982a1bd-a4f4-4db9-9798-9b1e9ae34348

Reported adverse events (FAERS/openFDA)#

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