Colemerg Antibacterial Hand Sanitizing Wipes
FDA Label NDC 80171-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Colemerg Products Llc for the product Colemerg Antibacterial Hand Sanitizing Wipes (NDC 80171-002). 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 drug facts, active ingredient, purpose, uses, warnings, do not use:, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Benzalkonium Chloride 0.13 % w/v
Purpose
Antibacterial
Uses
- For sanitizing to decrease bacteria on the skin
- Recommended for repeated use
Warnings
For external use only
Do Not Use:
Over large areas of the body if you are allegic to any of the ingredients.
When Using This Product
do not get into eyes. If contact occurs, rinse thoroughly with water.
Stop Use And Ask A Doctor If
irritation or rash develops and continues for more than 72 hours.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222)
Directions
- Remove lid and open the seal.
- Pull up the corner of the center sheet, twist it and thread through the dispenser slipt in the lid.
- Pull sheet out at an angle. When finished close lid flap to retain moisure.
Other Information:
- Do not expose to direct sunlight, preferably place them in a cool place
- Do not use on furniture
- Do not flush down toilets, dispose in trash can
Inactive Ingredients:
Aqua/Water, Glycerin, Phenoxyethanol, Parfum/Fragrance, Polysorbate 20, Sodium PCA, Tetrasodium Edta, Ethylhexylglycerin, Citric Acid.
* Please review the disclaimer below.
