FDA.reportPublic FDA data

B-Pure Hand Sanitizer Spray, Pumpkin Scented

Manufacturer
FOURSTAR GROUP USA, INC.
Effective date
2025-05-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:46

Label at a glance#

ProductB-Pure Hand Sanitizer Pumpkin Scented
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

hand sanitizer to help reduce bacteria on skin

Dosage and administration

Spray into 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

Spray into hands and rub together briskly until dry.

Other information

SPL UNCLASSIFIED SECTION

Store below 110°F (43°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, fragrance, peg-40 hydrogenated castor oil, glycerin, pumpkin seed oil peg-8 esters, hexyl cinnamal, linalool, limonene

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

Package Labeling:59

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041849ethanol 70 % Topical SprayPSN2
1041849ethanol 0.7 ML/ML Topical SpraySCD2
1041849ethanol 70 % Topical SpraySY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-158-01B-Pure Hand Sanitizer Pumpkin Scented10 mL in 1 BOTTLELIQUID102
80684-158-02B-Pure Hand Sanitizer Pumpkin Scented59 mL in 1 BOTTLELIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-158B-PURE HAND SANITIZER PUMPKIN SCENTED (ALCOHOL) LIQUID [FOURSTAR GROUP USA, INC.]2Current NDC, 2 package rows20250511_7ea6ec9d-323d-4f81-bc86-94cd0e6cc014.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80684-15880684-158-01, 80684-158-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
LINALOOL, (+/-)-D81QY6I88EIACT
LIMONENE, (+)-GFD7C86Q1WIACT
ALCOHOL3K9958V90MACTIB

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
B-Pure Hand Sanitizer Pumpkin ScentedALCOHOLFOURSTAR GROUP USA, INC.7ea6ec9d-323d-4f81-bc86-94cd0e6cc0142025-05-07WarningsExact identifier
ndc (package): 80684-158-02
ndc (package): 80684-158-01
ndc (product): 80684-158
ndc11 (package): 80684015801
ndc11 (package): 80684015802
spl id: 348d3c6b-ebb4-473c-e063-6294a90a070c
spl set id: 7ea6ec9d-323d-4f81-bc86-94cd0e6cc014

Reported adverse events (FAERS/openFDA)#

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