Active Ingredient
Benzalkonium Chloride 0.13% w/w
Fusion Antibacterial Wipes
FDA Label NDC 80336-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fusion Products Ltd. for the product Fusion Antibacterial Wipes (NDC 80336-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
For hand washing to decrease bacteria on the skin.
Warnings
For external use only
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - When Using
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash appears and lasts
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.
Directions
Apply to clean dry hands.
Wet hands thoroughly with the product and allow to dry
Children under 6 should be supervised when using this product
Other Information
Do not store above 104°F (40°C)
Do not use if seal is missing or broken
Inactive Ingredients
aloe barbadensis leaf juice, decyl glucoside, glycerin, water.
Package Label.Principal Display Panel
70 WIPES, NDC: 80336-004-09
* Please review the disclaimer below.
