FDA Label for Disinfectant Wipes
View Indications, Usage & Precautions
Disinfectant Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Mb Diversity. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
- If you have Respiratory problems.
- On open skin wounds.
- If you suffer from dermatitis, psoriasis, excema.
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.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - 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.
Warnings
For external use only. Flammable. Keep away from heat or flame
Directions
- 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
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Laureth-9 Phosphate, Glycerin, DMDM Hydantoin, Fragrance, RO Water USP
Recent Major Changes
Drug Facts
Active Ingredient
Purpose
Benzalkonium Chloride 0.50%v/v...........................................Antiseptic, Surface Wipe
Isopropyl Alcohol 4% v/v…………………..………….. Antiseptic, Properly Dilutes BKC
Uses
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.
Warnings
For multipurpose surface disinfectant or external use only - if you have sensitive skin, use gloves for prolonged exposure to protect hands. People with skin conditions of open wounds should avoid direct contact. Asthmatics or people with respiratory problems should use a respirator to avoid inhaling fumes.
Flammable. Keep away from heat or flame.
Do not use
If you have Respiratory problems.
On open skin wounds.
If you suffer from dermatitis, psoriasis, excema
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 a rash or skin irritation 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
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
Avoid freezing and excessive heat above 104°F
Store between 59°-86°F
May discolor some fabrics
Harmful to untreated wood, some plastics, untreated grout.
Inactive Ingredients
Laureth-9 Phosphate, Glycerin, DMDM Hydantoin, Fragrance, RO Water USP
Package Label - Principal Display Panel
480 mL NDC: 78833-010-01
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