FVJIA DISINFECTANT- didecyl dimethyl ammonium chloride, benzalkonium chloride spray 
Hunan Fujia Environmental Safety Technology Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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 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.

Directions

Other information

Inactive ingredients

Polyhexamethylene biguanide hydrochloride
Distilled water
Glutaric dialdehyde

Package Label - Principal Display Panel

123

FVJIA DISINFECTANT 
didecyl dimethyl ammonium chloride, benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82170-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 g  in 100 mL
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)  
GLUTARALDEHYDE (UNII: T3C89M417N)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82170-101-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2021
2NDC:82170-101-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2021
3NDC:82170-101-03240 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/18/2021
Labeler - Hunan Fujia Environmental Safety Technology Co., Ltd (711713369)
Establishment
NameAddressID/FEIBusiness Operations
Hunan Fujia Environmental Safety Technology Co., Ltd711713369manufacture(82170-101)

Revised: 5/2022
Document Id: df4506e5-014e-6753-e053-2995a90a37c6
Set id: c9d776a3-2906-3f13-e053-2995a90ae9e3
Version: 3
Effective Time: 20220518
 
Hunan Fujia Environmental Safety Technology Co., Ltd