Label: DISINFECTANT WIPES- benzalkonium chloride/ isopropyl alcohol cloth
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated July 7, 2020
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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)
- 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
- KEEP OUT OF REACH OF CHILDREN
- Wipe generously on non porous surfaces to completely cover.
- Wipe until clean, allow to remain visibly wet until surfaces air dry.
- After disinfecting, thoroughly rinse surfaces, with potable water, before coming into direct contact with food.
- Children under 6 years of age should not be using this product.
- Throw away soiled wipes, do not reuse.
- Dispose of wipes in the trash, do not throw into the toilet.
- Avoid eye contact, or swallowing.
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
benzalkonium chloride/ isopropyl alcohol cloth
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78833-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 4 mL in 100 mL BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:78833-010-01 480 mL in 1 CYLINDER; Type 0: Not a Combination Product 07/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/08/2020 Labeler - MB Diversity (079725725) Establishment Name Address ID/FEI Business Operations MB Diversity 079725725 relabel(78833-010)