DISINFECTANT WIPES- benzalkonium chloride/ isopropyl alcohol cloth 
MB Diversity

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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Disinfectant Wipes

OTC Monograph Not Final

This is a disinfectant wipe manufacturered according to the FDA Monograph Not Final, regarding Benzalkonium Chloride as a disinfectant, which may be used to battle COVID-19. It has proven effective at destroying coronavirus' envelopes, and many other biocide functions for years. We chose a solution of 0.50% BZK concentration to prevent any topical skin irritation, which has been documented at levels of ≥1% concentrations. We also advise anyone with skin conditions to wear gloves, or any Respiratory problems to use a sufficient Respirator, such as an N-95, because inhalation of BZK has shown complications with individuals who have severe asthma or other Respiratory Problems. We also advise rinsing disinfected surfaces with potable water before placing food on them, to prevent any unwanted ingestions of the BKS.

BKC formulation kills 99.99% of most bacteria, and also influenza as well as molds.

Less than a year ago, the Food and Drug Administration went even further, green-lighting the over-the-counter sale of BZK-manufactured hand hygiene products.

Active Ingredient(s)

Benzalkonium Chloride 0.5% v/v. Purpose Antiseptic

Alcohol 4% v/v. Purpose: Antiseptic, Necessary to Dilluted BKC

Purpose

Antiseptic, Multi Surface Disinfectant, and Topical Antiseptic

Use

Multi-surface and topical Disinfectant wipe to help reduce bacteria that potentially can cause disease.

For use on Non-Porous surfaces to aid in disinfecting.

Recommended for repeated use.

Do not use

When using this product

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Avoid contact with broken skin.

Do not inhale fumes or ingest.

Keep out of reach of children.

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

Avoid use on untreated wood or porous surfaces.

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.

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions

Other information

Inactive ingredients

Laureth-9 Phosphate, Glycerin, DMDM Hydantoin, Fragrance, RO Water USP

Package Label - Principal Display Panel

480 mL NDC: 78833-010-01

1

DISINFECTANT WIPES 
benzalkonium chloride/ isopropyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78833-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL4 mL  in 100 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DMDM HYDANTOIN (UNII: BYR0546TOW) 0.2 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 87.104 mL  in 100 mL
CITRONELLAL (UNII: QB99VZZ7GZ) 0.016 mL  in 100 mL
.ALPHA.-PINENE (UNII: JPF3YI7O34) 0.016 mL  in 100 mL
LINALOOL, (+)- (UNII: F4VNO44C09) 0.016 mL  in 100 mL
LINALYL ACETATE (UNII: 5K47SSQ51G) 0.02 mL  in 100 mL
MYRCENE (UNII: 3M39CZS25B) 0.016 mL  in 100 mL
LIMONENE DIEPOXIDE (UNII: M6TUW5WEJ9) 0.016 mL  in 100 mL
2-METHOXY-1-PROPANOL (UNII: 18B570XOYF) 0.016 mL  in 100 mL
CITRAL (UNII: T7EU0O9VPP) 0.016 mL  in 100 mL
4-METHYL-1,4-PENTANEDIYL DIMETHACRYLATE (UNII: 3BHT04VYO9) 0.016 mL  in 100 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40) 0.016 mL  in 100 mL
LAURETH-9 PHOSPHATE (UNII: 0N8G76HI1O) 5 mL  in 100 mL
.BETA.-PINENE (UNII: 4MS8VHZ1HJ) 0.016 mL  in 100 mL
TERPINOLENE (UNII: N9830X5KSL) 0.016 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78833-010-01480 mL in 1 CYLINDER; Type 0: Not a Combination Product07/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/08/2020
Labeler - MB Diversity (079725725)
Establishment
NameAddressID/FEIBusiness Operations
MB Diversity079725725relabel(78833-010)

Revised: 7/2020
Document Id: a74b102b-d7f2-9f90-e053-2995a90a748a
Set id: a74b1b4c-d952-a0b9-e053-2995a90a2a37
Version: 1
Effective Time: 20200707
 
MB Diversity