SANTOTIZER E80- FRAGRANCE- hand sanitizer solution liquid

SantOtizer E80- FRAGRANCE by

Drug Labeling and Warnings

SantOtizer E80- FRAGRANCE by is a Otc medication manufactured, distributed, or labeled by SantoLubes LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 80% v/v

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Use[s]

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

WARNINGS

Warnings

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

DO NOT USE

Do not use

In children less than 2 months of age
On open skin wounds

WHEN USING

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

STOP USE

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

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

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.

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

fragrance, glycerin, hydrogen peroxide, purified water

PRINCIPAL DISPLAY PANEL

3,600ml NDC: 73976-3304-1

18,000ml NDC: 73976-3304-2

200,000ml NDC: 73976-3304-3

1,022,00ml NDC: 73976-3304-4

INGREDIENTS AND APPEARANCE

SANTOTIZER E80- FRAGRANCE 
hand sanitizer solution liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73976-3304
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
WATER (UNII: 059QF0KO0R)	18.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73976-3304-1	3600 mL in 1 PAIL; Type 0: Not a Combination Product	06/12/2020
2	NDC: 73976-3304-2	18000 mL in 1 PAIL; Type 0: Not a Combination Product	06/12/2020
3	NDC: 73976-3304-3	200000 mL in 1 DRUM; Type 0: Not a Combination Product	06/12/2020
4	NDC: 73976-3304-4	1022000 mL in 1 TANK; Type 0: Not a Combination Product	06/12/2020
5	NDC: 73976-3304-6	38.4456 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/14/2020

Labeler - SantoLubes LLC (144734980)

Registrant - SantoLubes LLC (144734980)

Establishment
Name	Address	ID/FEI	Business Operations
SantoLubes LLC		144734980	manufacture(73976-3304)