Active Ingredient(S)
Benzalkonium Chloride 0.184% w/w, Purspose: Antimicrobial
Didecyldimonium Chloride 0.2% w/w, Purspose: Antimicrobial
Disinfecting Wipes
FDA Label NDC 80297-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tmd Holdings, Llc for the product Disinfecting Wipes (NDC 80297-031). 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, Hand Sanitizer
Use
For hand washing to help reduce bacteria on the skin.
Warnings
For external use only. Flammable. Keep away from heat or flame
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 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.
Otc - Stop Use
Stop use and ask a doctor if irritation develops and persists for more than 72 hours.
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
- For use apply thoroughly to hands as desired. Allow to dry without wiping. Discard wipe in trash after use. Do not flush.
- For dispensing flip open dispensing cap and remove entire lid from canister by lifting upward.
- Locate wipe at center of roll, twist corner to a point and thread through small opening in lid.
- DO NOT PUSH FINGER THROUGH OPENING.
- Replace lid and pull sheet up at an angle. Remaining wipes feed automatically.
- When finished, snap lid cap shut to retain moisture.
Other Information
- Store below 110F(43C)
- May discolor certain fabrics.
Inactive Ingredients
Ethylhexylglycerin, Glycerin, Fragrance(Parfum), Phenoxyethanol, Propylene Glycol, Purified water
Package Label - Principal Display Panel
160 Wipes NDC: 80297-031-01
* Please review the disclaimer below.
