Dosage & Administration
Product NDC: 81311-025:
Directions: Place 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.
Bioshield 99 Alcohol
FDA Label NDC 81627-025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naturally Safe Solutions, Llc for the product Bioshield 99 Alcohol (NDC 81627-025). 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 dosage & administration, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, warnings, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Product NDC: 81311-025:
HYDROGEN PEROXIDE, GLYCERIN, CINNAMON OIL, ANHYDROUS CITRIC ACID, WATER
Indications & Usage
Product NDC: 81311-025:
Use(s): Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Otc - Keep Out Of Reach Of Children
Product NDC: 81311-025:
If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Otc - Purpose
Product NDC: 81311-025:
Antiseptic
Otc - Active Ingredient
Product NDC: 81311-025:
Alcohol 80% v/v
Warnings
Product NDC: 81311-025:
For external use only. Flammable. Keep away from heat or flame
Otc - Do Not Use
Product NDC: 81311-025:
in children less than 2 months of age • on open skin wounds
Otc - When Using
Product NDC: 81311-025:
keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Product NDC: 81311-025:
if irritation or rash occurs. These may be signs of a serious condition.
Other Safety Information
Product NDC: 81311-025:
Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
Package Label.Principal Display Panel
60 mL NDC: 81627-015-02
300 mL NDC: 81627-015-10
1000 mL NDC: 81627-015-32
3785 mL NDC: 81627-015-50
60 mL NDC: 81627-025-02
2oz With Alcohol (Sani 2oz)
300 mL NDC: 81627-025-10
10oz With Alcohol (Sani 10oz)
1000 mL NDC: 81627-025-32
32oz With Alcohol (Sani 32oz)
3785 mL NDC: 81627-025-50
128oz With Alcohol (Sani 1g)
* Please review the disclaimer below.
