HAND SANITIZER WITH REAL LEMON ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION- alcohol solution

Hand Sanitizer with Real Lemon Alcohol Antiseptic 80% Topical Solution by

Drug Labeling and Warnings

Hand Sanitizer with Real Lemon Alcohol Antiseptic 80% Topical Solution by is a Otc medication manufactured, distributed, or labeled by Fabrizia Spirits, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Alcohol 80% v/v. Purpose: Antiseptic

PURPOSE

Use

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

WARNINGS

Warnings

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

DOSAGE & ADMINISTRATION

Directions

• 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.

INACTIVE INGREDIENT

Inactive ingredients: glycerin, tert-butyl alcohol, bitrex (denatonium benzoate), hydrogen peroxide, lemon oil, purified water

STORAGE AND HANDLING

Other information

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

Package Label - Principal Display Panel

Fabrizia

Hand Sanitizer

with Real Lemon

Alcohol Antiseptic 80% Topical Solution

Non-Sterile Solution

118 ml

INGREDIENTS AND APPEARANCE

HAND SANITIZER WITH REAL LEMON ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77322-005
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
LEMON OIL (UNII: I9GRO824LL)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77322-005-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
2	NDC: 77322-005-02	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
3	NDC: 77322-005-03	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
4	NDC: 77322-005-04	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Fabrizia Spirits, LLC (063388203)

Establishment
Name	Address	ID/FEI	Business Operations
Fabrizia Spirits, LLC		063388203	manufacture(77322-005)