COCONUT SCENTED HAND SANITIZER SPRAY PEN

Manufacturer
Fourstar Group USA, Inc.
Effective date
2024-07-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:15:39

Label at a glance#

ProductCOCONUT SCENTED HAND SANITIZER PEN
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

hand sanitizer to help reduce bacteria on skin

Dosage and administration

Put a dime sized drop onto hands and rub together briskly until dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol, 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

hand sanitizer to help reduce bacteria on skin

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation, excessive redness or rash develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Put a dime sized drop onto hands and rub together briskly until dry.

Other information

SPL UNCLASSIFIED SECTION

Store below 110°F (43°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, fragrance, denatonium benzoate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle03Bottle03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041849ethanol 70 % Topical SprayPSN3
1041849ethanol 0.7 ML/ML Topical SpraySCD3
1041849ethanol 70 % Topical SpraySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80684-092-002024-01-30C16284748780-11030e365-563f-111a-e063-dadaa90a10e2COCONUT SCENTED HAND SANITIZER SPRAY PEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-092-00COCONUT SCENTED HAND SANITIZER PEN10 mL in 1 BOTTLE, SPRAYLIQUID103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-092COCONUT SCENTED HAND SANITIZER PEN (ALCOHOL) LIQUID [FOURSTAR GROUP USA, INC.]3Current NDC, Legacy NDC, 1 package rows20240720_2fa53710-c084-48e0-8300-511d0d93a88d.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80684-09280684-092-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
COCONUT SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Inc.2fa53710-c084-48e0-8300-511d0d93a88d2024-07-18WarningsExact identifier
ndc (package): 80684-092-00
ndc (product): 80684-092
ndc11 (package): 80684009200
spl id: 1d8d1018-6965-c39c-e063-6294a90a5754
spl set id: 2fa53710-c084-48e0-8300-511d0d93a88d

Reported adverse events (FAERS/openFDA)#

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