FDA.reportPublic FDA data

Santorini Hand Mist

Manufacturer
Antica Farmacista, LLC | SALON TECHNOLOGIES INTERNATIONAL, INC
Effective date
2021-03-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:48:36

Label at a glance#

ProductSantorini Hand Mist
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age.

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol, Denatured 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

USES:

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS:

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use

  • With children less than 2 months of age
  • On open skin wounds
  • Near eyes.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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.

OTHER INFORMATION:

STORAGE AND HANDLING SECTION

Store between 15-30°C (59-86°F)

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Purified water USP, Glycerin, Fragrance.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 FL. OZ / 59ML

NDC: 80097-006-01 LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80097-00680097-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
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
0ec40052-975f-b389-e063-6394a90a33f9bdccc6d0-575e-3b90-e053-2995a90a6cca2024-01-12WarningsExact identifier
spl set id: bdccc6d0-575e-3b90-e053-2995a90a6cca

Reported adverse events (FAERS/openFDA)#

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