HAND SANITIZER GEL with LEMON ESSENTIAL OIL

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SPEZIERIE PALAZZO VECCHIO DOTT. DI MASSIMO SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
SPEZIERIE PALAZZO VECCHIO DOTT. DI MASSIMO SRL

----------

HAND SANITIZER GEL with LEMON ESSENTIAL OIL

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70,5%, weight/weight (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1% w/w).
3. Hydrogen peroxide (0.035% w/w).
4. Sterile distilled water or boiled cold water.
5. Aloe barbadensis leaf juice 1 - 5%
6. Hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer 0.1 - 1%
7. Squalane 0.1 - 1%
8. Xanthan gum 0.1 - 1%
9. Polysorbate 60 0.1 - 1%
10. CITRUS LIMON PEEL OIL (0,07290%)
11. Sorbitan isostearate 0 - 0.1%
12. Chlorhexidine digluconate 0 - 0.1%
13. LACTIC ACID (0,01500%)

Active Ingredient(s)

Alcohol 70,5% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

• 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.

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 when using this product to avoid swallowing.

Other information

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP, Aloe barbadensis leaf juic, Hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, Squalane, Xanthan gum, Polysorbate 60, CITRUS LIMON PEEL OIL , Sorbitan isostearate, Chlorhexidine digluconate, LACTIC ACID

Package Label - Principal Display Panel

NDC: 81800-657-02

1000 mL NDC: 81800-657-01

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81800-657
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)	0.1 mL  in 100 mL
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)	0.072 mL  in 100 mL
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)	0.1 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.035 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
POLYSORBATE 60 (UNII: CAL22UVI4M)	0.1 mL  in 100 mL
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)	1 mL  in 100 mL
SQUALANE (UNII: GW89575KF9)	0.1 mL  in 100 mL
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)	0.015 mL  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE)	0.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81800-657-01	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020
2	NDC: 81800-657-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	03/30/2020	06/15/2022

Labeler - SPEZIERIE PALAZZO VECCHIO DOTT. DI MASSIMO SRL (431217616)

Registrant - SPEZIERIE PALAZZO VECCHIO DOTT. DI MASSIMO SRL (431217616)

Establishment
Name	Address	ID/FEI	Business Operations
SPEZIERIE PALAZZO VECCHIO DOTT. DI MASSIMO SRL		431217616	manufacture(81800-657)

Revised: 10/2025

Document Id: 41fa0662-cb96-2d1a-e063-6294a90ad1ed

34390-5

Set id: bf797195-ff0f-aa94-e053-2995a90a8164

Version: 2

Effective Time: 20251025

 

SPEZIE