FDA.reportPublic FDA data

B-Pure Moisturizing Hand Sanitizer, Polar Berry Scented

Manufacturer
Fourstar Group USA, Inc.
Effective date
2026-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-13 05:10:08

Label at a glance#

ProductB-Pure Moisturizing Hand Sanitizer Polar Berry Scented
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

hand sanitizer to help reduce bacteria on skin

Dosage and administration

Spray product in hands and rub together.

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 product in hands and rub together.

Other information

SPL UNCLASSIFIED SECTION

Store below 110°F (43°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, fragrance, glycerin, denatonium benzoate, benzyl alcohol, linalool, citronellol limonene, linalyl acetate, citrus aurantium dulcis peel oil, citrus sinensis peel oil, ext. violet 2, blue 1

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label01.jpgLabel01.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130049696838474GTIN-13: 0049696838474
EAN-13: 0049696838474
GTIN-12: 049696838474
UPC-A: 049696838474
GTIN storage (14 digits): 00049696838474		Label01.jpg

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80684-21680684-216-01

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
BENZYL ALCOHOLLKG8494WBHIACT
LINALOOL, (+/-)-D81QY6I88EIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALYL ACETATE5K47SSQ51GIACT
D&C VIOLET NO. 2350KA7O6HKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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 Moisturizing Hand Sanitizer Polar Berry ScentedALCOHOLFourstar Group USA, Inc.d1fa6ca0-ba85-4bb7-a7ae-b9ac0c39ea352026-06-09WarningsExact identifier
ndc (package): 80684-216-01
ndc (product): 80684-216
ndc11 (package): 80684021601
spl id: 53d8b6fd-2184-7ade-e063-6394a90a67b4
spl set id: d1fa6ca0-ba85-4bb7-a7ae-b9ac0c39ea35

Reported adverse events (FAERS/openFDA)#

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