FDA.reportPublic FDA data

b pure Hydrating Hand Sanitizer Salted Caramel Scented

Manufacturer
FOURSTAR GROUP USA, INC.
Effective date
2024-06-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:28

Label at a glance#

Productb pure Hydrating Hand Sanitizer Salted Caramel 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 c hildren.

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, hexyl cinnamal, linalool, limonene, coumarin, alpha-isomethyl ionone, yellow 6, yellow 5

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label..jpgLabel..jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041849ethanol 70 % Topical SprayPSN1
1041849ethanol 0.7 ML/ML Topical SpraySCD1
1041849ethanol 70 % Topical SpraySY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-106-00b pure Hydrating Hand Sanitizer Salted Caramel Scented30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-106B PURE HYDRATING HAND SANITIZER SALTED CARAMEL SCENTED (ALCOHOL) LIQUID [FOURSTAR GROUP USA, INC.]1Current NDC, 1 package rows20240805_1a38e171-e2fb-206c-e063-6294a90ac638.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80684-10680684-106-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
LINALOOL, (+/-)-D81QY6I88EIACT
LIMONENE, (+)-GFD7C86Q1WIACT
COUMARINA4VZ22K1WTIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
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 Hydrating Hand Sanitizer Salted Caramel ScentedALCOHOLFOURSTAR GROUP USA, INC.1a38e171-e2fb-206c-e063-6294a90ac6382024-06-06WarningsExact identifier
ndc (package): 80684-106-00
ndc (product): 80684-106
ndc11 (package): 80684010600
spl id: 1a38e17b-31fa-4cc8-e063-6294a90a7b8c
spl set id: 1a38e171-e2fb-206c-e063-6294a90ac638

Reported adverse events (FAERS/openFDA)#

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