Santorini Hand Mist by Antica Farmacista, LLC / SALON TECHNOLOGIES INTERNATIONAL, INC Santorini Hand Mist

Santorini Hand Mist by

Drug Labeling and Warnings

Santorini Hand Mist by is a Otc medication manufactured, distributed, or labeled by Antica Farmacista, LLC, SALON TECHNOLOGIES INTERNATIONAL, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANTORINI HAND MIST- alcohol spray 
Antica Farmacista, LLC

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Santorini Hand Mist

DRUG FACTS

ACTIVE INGREDIENTS

Ethyl Alcohol, Denatured 80% v/v

Purpose

Antiseptic

USES:

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

WARNINGS:

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

Do not use

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

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.

DIRECTIONS:

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

OTHER INFORMATION:

Store between 15-30°C (59-86°F)

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

INACTIVE INGREDIENTS:

Purified water USP, Glycerin, Fragrance.

2 FL. OZ / 59ML

NDC: 80097-006-01

SANTORINI HAND MIST 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80097-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80097-006-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/15/2021	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	03/15/2021	03/01/2023

Labeler - Antica Farmacista, LLC (171114395)

Registrant - SALON TECHNOLOGIES INTERNATIONAL, INC (877118302)

Establishment
Name	Address	ID/FEI	Business Operations
SALON TECHNOLOGIES INTERNATIONAL, INC		877118302	manufacture(80097-006)

Revised: 1/2024

Document Id: 0ec40052-975f-b389-e063-6394a90a33f9

34390-5

Set id: bdccc6d0-575e-3b90-e053-2995a90a6cca

Version: 3

Effective Time: 20240112