HANDSOAP- benzalkonium chloride liquid

HandSoap by

Drug Labeling and Warnings

HandSoap by is a Otc medication manufactured, distributed, or labeled by Campari Science & Technology (Suzhou) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.45%、CHLORHEXIDINE DIGLUCONATE 0.20%

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

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

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.

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

WATER、COCAMIDOPROPYL BETAINE、DECYL GLUCOSIDE、GLYCERIN、COCAMIDOPROPYLAMINE OXIDE、SODIUM CITRATE、ARTEMISIA ARGYI LEAF EXTRACT、SODIUM HYDROXIDE、PARFUM

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HANDSOAP 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54837-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	2.25 mg  in 500 mL
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	1 mg  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54837-002-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/15/2020

Labeler - Campari Science & Technology (Suzhou) Co., Ltd. (548374083)

Establishment
Name	Address	ID/FEI	Business Operations
Campari Science & Technology (Suzhou) Co., Ltd.		548374083	manufacture(54837-002)