FDA.reportPublic FDA data

P b pure Antibacterial Hand Sanitizer Gel Ocean Breeze Scented

Manufacturer
FOURSTAR GROUP USA, INC.
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:02

Label at a glance#

ProductP b pure Antibacterial Hand Sanitizer Ocean Breeze Scented
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, 65% 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, propylene glycol, fragrance, carbomer, triethanolamine, blue 1

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN2
902574ethanol 0.65 ML/ML Topical GelSCD2
902574ethyl alcohol 65 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-001-01P b pure Antibacterial Hand Sanitizer Ocean Breeze Scented29 mL in 1 BOTTLEGEL292

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-001P B PURE ANTIBACTERIAL HAND SANITIZER OCEAN BREEZE SCENTED (ALCOHOL) GEL [FOURSTAR GROUP USA, INC.]2Current NDC, Legacy NDC, 1 package rows20231027_b17d3da6-a0f8-55d2-e053-2995a90a6ab9.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
80684-00180684-001-01

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
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
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
P b pure Antibacterial Hand Sanitizer Ocean Breeze ScentedALCOHOLFOURSTAR GROUP USA, INC.b17d3da6-a0f8-55d2-e053-2995a90a6ab92023-10-26WarningsExact identifier
ndc (package): 80684-001-01
ndc (product): 80684-001
ndc11 (package): 80684000101
spl id: 089fffdd-2eed-6928-e063-6294a90af1c6
spl set id: b17d3da6-a0f8-55d2-e053-2995a90a6ab9

Reported adverse events (FAERS/openFDA)#

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