SUBSTANCE SURFACE DISINFECTANT gel

Substance surface disinfectant by

Drug Labeling and Warnings

Substance surface disinfectant by is a Otc medication manufactured, distributed, or labeled by Hangzhou Changing Time Biotechnology Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium chloride 0.2% v/v.

PURPOSE

Antimicrobial

USES

Used for disinfection in the space, general substance surface(wall,floor,stool, bathtub,table), mobile phone,computer, fabric,furniture,surface, skin, etc

WARNINGS

For external use only.

DO NOT USE

WHEN USING SECTION

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

Use soon after opening.Use by pressing the nozzle placing outwards Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15℃-30℃(59°F-86°F)

Avoid freezing and excessive heat above 40C(104F)

INACTIVE INGREDIENTS

Aqua, Polihexanide Hydrochloride.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

SUBSTANCE SURFACE DISINFECTANT 
substance surface disinfectant gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75153-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75153-002-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2020
2	NDC: 75153-002-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2020
3	NDC: 75153-002-03	208198 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/26/2020

Labeler - Hangzhou Changing Time Biotechnology Co.,Ltd (554529093)

Registrant - Hangzhou Changing Time Biotechnology Co.,Ltd (554529093)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Changing Time Biotechnology Co.,Ltd		554529093	manufacture(75153-002)