FVJIA DISINFECTANT- didecyl dimethyl ammonium chloride, benzalkonium chloride spray

FVJIA disinfectant by

Drug Labeling and Warnings

FVJIA disinfectant by is a Otc medication manufactured, distributed, or labeled by Hunan Fujia Environmental Safety Technology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

FVJIA disinfectant

Active Ingredient(s)

Didecyl Dimethyl Ammonium Chloride 0.60g/100mL

Benzalkonium chloride 0.20g/100mL

Purpose

Antiseptic

Use

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

Warnings

For external use only.

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

• Spray on the surface of the skin and let it dry naturally

Other information

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

Inactive ingredients

Polyhexamethylene biguanide hydrochloride
Distilled water
Glutaric dialdehyde

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

FVJIA DISINFECTANT 
didecyl dimethyl ammonium chloride, benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82170-101
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
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	0.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)
GLUTARALDEHYDE (UNII: T3C89M417N)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82170-101-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2021
2	NDC: 82170-101-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2021
3	NDC: 82170-101-03	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/18/2021

Labeler - Hunan Fujia Environmental Safety Technology Co., Ltd (711713369)

Establishment
Name	Address	ID/FEI	Business Operations
Hunan Fujia Environmental Safety Technology Co., Ltd		711713369	manufacture(82170-101)