CLEAN DISINFECTANT WIPES- benzalkonium chloride liquid

Clean Disinfectant Wipes by

Drug Labeling and Warnings

Clean Disinfectant Wipes by is a Otc medication manufactured, distributed, or labeled by Clean One Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride

INACTIVE INGREDIENTS

Water, Citric Acid

PURPOSE

Antiseptic

WARNINGS

For external use only.
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Do not use
■ in children less than 2 months of age
■ on open skin wounds
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When using this product
■ avoid getting into the eyes (if contact occurs, wash well with clean water)
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Stop use and ask a doctor
■ hypersensitivity symptoms such as erythema, itching and dermatitis happen
■ skin irritation happens

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Hand sanitizing wipes to help reduce bacteria that potentially can cause disease.

Directions

■ Wet hands thoroughly with product and allow to dry without wiping
■ Do not flush
■ Children under 2 years ask a doctor before use

Other information

■ Read the directions and warnings before use
■ Store between 15-30℃(59-89℉)
■ Avoid freezing and excessive heat above 40℃(104 ℉)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEAN DISINFECTANT WIPES 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78506-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0054 g  in 3.6 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78506-001-01	3.6 g in 1 PACKET; Type 0: Not a Combination Product	09/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/08/2020

Labeler - Clean One Co., Ltd. (688986083)

Registrant - Clean One Co., Ltd. (688986083)

Establishment
Name	Address	ID/FEI	Business Operations
Clean One Co., Ltd.		688986083	manufacture(78506-001)