Hand Sanitizer
FDA Label NDC 78684-080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Still Valley Spirits Llc for the product Hand Sanitizer (NDC 78684-080). 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 drug facts, active ingredient(s), purpose(s), uses(s), warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient(S)
Denatured Ethyl Alcohol 80% v/v
Purpose(S)
Antiseptic
Uses(S)
Hand sanitizer to help reduce bacteria that can potentially cause disease. For use when soap or water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
• on children less than 2 months of age
• on open skin wounds
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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
• Spray enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
• Store between 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)
Inactive Ingredient(S)
• Distilled or Boiled Water, Hydrogen Peroxide, Glycerin
Packaging
Image (Stvls)
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