Active Ingredient
Ethyl Alcohol 62% v/v
Foaming Mousse Hand Sanitizer
FDA Label NDC 17630-3093
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Accra Pac, Inc. (dba Kik-indiana) for the product Foaming Mousse Hand Sanitizer (NDC 17630-3093). 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, uses, warnings, when using this product, stop use and ask a physician, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
- To help decrease bact:eriafgerms on the sk!in that could cause
- Recommended for repeated use.
disease. For use when soap and water are not available.
Warnings
Warnings
For external use only
• Do not puncture or incinerate.
• Do not store above 120°F (49°C).
When Using This Product
• Avoid contact with eyes.
• It splashed in eyes, rinse immediately and thoroughly with water.
• Do not use on chil'dren under 2 months of age.
• Do not use on open wounds.
• Discontinue use if irritation/redness occurs.
Stop Use And Ask A Physician
Stop use and ask a physician if irritation occurs for more than 3 days, contact a physician.
Keep Out Of Reach Of Children
• In case of ingestion, get medical help or contact a Poison Control Center immediately.
Directions
• Shake well before using.
• Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing untiil hands feel dry. Do not rinse or wipe off sanitizer.
• Supervise children under 6 years of age when using this product to avoid swallowing.
Dosage & Administration
• Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing untiil hands feel dry. Do not rinse or wipe off sanitizer.
Other Information
• For best benefit, store and use are 55-85° F (13-29°C).
Inactive Ingredient
Water, Hydrofluorocarbon 152a, lsobutane, Emulsifying Wax., Cetyl Lactate, Steareth-2, Sodium Benzoate, Sodium Sesquicarbonate.
Fragrance
Principal Display Panel
200 mL NDC: 17630-3093-1
Paya®
HAND
SANITIZER
ANTISEPTIC
FOAM
62% v/v
Ethyl alcohol*
Fast-acting
No Rinsing!
Lightweight
formula
*Non-Sterile Solution.
Net Wt: 7 oz (2 00g)
* Please review the disclaimer below.
