Active Ingredient(S)
Ethyl Alcohol 75% v/v. Purpose: Antimicrobial
Pl Hand Sanitizer Wipe
FDA Label NDC 80479-175
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newport Mfg Llc for the product Pl Hand Sanitizer Wipe (NDC 80479-175). 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
Antimicrobial
Use
- to decrease bacteria on skin
- recommended for repeated use
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
- Do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.
- Avoid contact with broken skin
- Do not inhale or ingest
Otc - Stop Use
- Irritation or redness develops.
- Condition 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
- Wet hands thoroughly with product and allow drying without wiping.
- For children under 6, use only with adult supervision.
- Not recommended for use on infants.
Other Information
- Store between 20-25C (67-77F)
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Citrus Limon Peel Oil, D-Limonene, Glycerin, Tocopherol Acetate (Vitamin E), Water
Package Label - Principal Display Panel
80479-175-01 Single Wipe Packaging Pouch (Bernalwipe Final)
80479-175-40 Principal Packaging Box Wipe 40 Pack (Box40 Bernal Final 2)
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