Active Ingredient
Ethyl Alcohol (Ethanol) 70%
Alcohol Hand Wipes
FDA Label NDC 78141-211
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fuson Llc for the product Alcohol Hand Wipes (NDC 78141-211). 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, inactive ingredients, purpose, use, warnings, do not use, when using, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Aqua, glycerin, peg-7 glyceryl cocoate, polysorbate 20, cocamidopropyl betaine, dexpanthenol, citrus limon peel, citric acid, EDTA
Purpose
Antiseptic- Antibacterial hand towelettes
Use
Wipes used on hands and skin to reduce bacteria
Warnings
For external use only, do not ingest. Do not use near eyes. Keep away from flame and direct sunlight. Do not eat, drink, or smoke during use. If irritation or redness occurs and persists for longer than 72 hours, consult a medical professional.
Do Not Use
Do not use near eyes. Do not ingest. Do not eat, smoke, or drink during use. Do not use on or in open skin wounds. Do not use on children under 2 months of age.
When Using
If ingested, contact a poison control center immediately. If eye contact occurs, flush eyes with water repeatidly.
Stop Use
Stop use if redness, irritation, or rash occurs.
Otc - Keep Out Of Reach Of Children
Store in places out of reach of children. Supervise use by children under the age of 6.
Dierctions
Peel back open label slowly. Pull out one wipe at a time and re-seal the packaging tightly. Wet hands thoroughly with product and allow to dry without wiping.
Storage
Keep away from direct sunlight. Store tightly closed in its original packaging and in a cool, dry place. Keep away from food, drinks, and animal feed. Store away from reach of children.
Package Label
120 Count Canister: 78141-211-12
200 Count Canister: 78141-211-20
500 Count Canister: 78141-211-50
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