FDA.reportPublic FDA data

FRESH GEL HAND ANTISEPTIC CLEANER 250 mL

Manufacturer
PROVINCE APOTHECARY INC
Effective date
2022-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:12:51

Label at a glance#

ProductFRESH HAND ANTISEPTIC CLEANER
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Dosage and administration

■ Place enough product on hands to cover all surfaces. Rub hands together until dry. ■ Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

■ Store between 15-30C (59-86F) ■ Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 60%

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

USES

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease.

WARNINGS

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

■ in children less than 2 months of age

■ on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • . If product is swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.

■ Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

■ Store between 15-30C (59-86F)

■ Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe Barbadensis Leaf Juice*, Glycerin, Eucalyptus Globulus Oil*, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, FD&C Blue 1.

*Certified organic

FRESH GEL HAND ANTISEPTIC CLEANER 250 mL (NDC 72257-250-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fresh Gel Hand Antiseptic Cleaner 250 mLFresh Gel Hand Antiseptic Cleaner 250 mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72257-250-012024-01-30C16284748780-11030e365-3762-111a-e063-dadaa90a10e2FRESH GEL HAND ANTISEPTIC CLEANER 250 mL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72257-250FRESH HAND ANTISEPTIC CLEANER (ETHYL ALCOHOL) GEL [PROVINCE APOTHECARY INC]2Legacy NDC20220123_a6bcdb52-cc75-f4b2-e053-2a95a90a5890.zip

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
72257-25072257-250-00, 72257-250-01

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
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
LAURETH-7Z95S6G8201IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER788QAG3W8AIACT
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
d62d3e15-7689-798a-e053-2a95a90a5abca6bcdb52-cc75-f4b2-e053-2a95a90a58902022-01-01WarningsExact identifier
spl id: d62d3e15-7689-798a-e053-2a95a90a5abc
spl set id: a6bcdb52-cc75-f4b2-e053-2a95a90a5890

Reported adverse events (FAERS/openFDA)#

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