Active Ingredient(S)
Benzalkonium Chloride 0.1%
Antibacterial Wipes Unscented
FDA Label NDC 80593-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhangzhou Wansike Electronics Co., Ltd for the product Antibacterial Wipes Unscented (NDC 80593-007). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
Hand sanitizer 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
·in children less than 2 months of age
·on open skin wounds
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 maybe signs of a serious condition.
Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center right away.
Do Not Use
Do not use
·in children less than 2 months of age
·on open skin wounds
Otc - When Using
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 maybe signs of a serious condition.
Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These maybe 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 Poison Control Center right away.
Directions
DIRECTIONS
·Open package.Pull wipe.Close package to retain moisture wet hands thoroughly with product.Allow to dry without rinsing.
·Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
Store between 15-30C (59-86F)
Avoid freezing and exessive heat aboce 40C (104F)
Inactive Ingredients
INACTIVE INGREDIENTS
Aloe Barbadensis Leaf Juice, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate, Water
Package Label - Principal Display Panel
10 solution in 1 package 80593-007-01
10 solution in 1 package 80593-007-02
10 solution in 1 package 80593-007-03
20 solution in 1 package 80593-007-04
20 solution in 1 package 80593-007-05
20 solution in 1 package 80593-007-06
20 solution in 1 canister 80593-007-07
40 solution in 1 canister 80593-007-08
80 solution in 1 canister 80593-007-09
100 solution in 1 canister 80593-007-10
* Please review the disclaimer below.
