SONO HAND SANITIZER- benzalkonium chloride solution

SONO Hand Sanitizer by

Drug Labeling and Warnings

SONO Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Advanced Ultrasound Solutions Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium chloride.........0.13%

Purpose

Antiseptic Hand Sanitizer

Uses

• Hand sanitizer to help reduce bacteria on skin
• Recommended for repeated use

Warnings

For external use only

Do not use in ears or mouth

When using this product

Avoid contact with eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor

If redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children

Children should be supervised when using this product

Directions

• Apply a small amount onto hand, then spread on both hands
• Rub hands together until dry

Inactive ingredients

Glycerin, PEG/PPG-18/18 Dimethicone, water, Organic Citrus Aurantium Bergamia Fruit Oil.

Sono Foaming Hand Sanitizer

INGREDIENTS AND APPEARANCE

SONO HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77677-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
WATER (UNII: 059QF0KO0R)
BERGAMOT OIL (UNII: 39W1PKE3JI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77677-001-02	50 g in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020
2	NDC: 77677-001-19	550 g in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/17/2020

Labeler - Advanced Ultrasound Solutions Inc. (079552984)

Registrant - Advanced Ultrasound Solutions Inc. (079552984)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.		028311595	manufacture(77677-001) , api manufacture(77677-001) , pack(77677-001)