Active Ingredient
Active ingredient for this sanitizing alcohol-free wipes is Benzalkonium chloride
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Active Ingredient (Activeingredient)
Sanitizing Alcohol Free Wipes
FDA Label NDC 80380-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shedrain Corporation for the product Sanitizing Alcohol Free Wipes (NDC 80380-100). 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, use, warnings, do not use, otc - stop use, otc - keep out of reach of children, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hand Sanitizer to help decrease bacteria on the skin.
Purpose (Usepurpose)
Use
For dispensing: Peel back front label at tab. Remove towelette wipes as needed. Reseal pouch by pressing label firmly back into place.
For use: Apply thoroughly to hands as desired. Allow to dry without wiping. Discard wipe in trash after use. Do not flush.
Indication (Use.)
Warnings
For external use only.
Warning (Warning)
Do Not Use
Do not use in or near the eyes. If contact occurs, flush thoroughly with water.
Do Not Use (Donotuse)
Otc - Stop Use
Stop use and contact doctor if redness and irritation develops and persists.
Stop Use (Stopuse)
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.
Keep Out Of Children (Keepoutofchildren)
Inactive Ingredients
Aqua (Water), Polyaminopropyl Biguanide, Xylitol Extract, Aloe Barbadensis Leaf Extract.
Inactive Ingredient (Inactiveingredient)
Dosage
FOR DISPENSING: Peel back front label at tab. Remove towelette wipes as needed.
FOR USE: Apply thoroughly to hands asdesired. Allow to dry without wiping.
Dosage And Administration (Dosage)
Package Label - Principal Display Panel
20-pack. NDC: 80380-100-01
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Package Label (Packagelabel)
* Please review the disclaimer below.
