Hand Sanitizer
FDA Label NDC 78304-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blakemore Sales Corporation for the product Hand Sanitizer (NDC 78304-004). 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, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Ethyl Alcohol 70% v/v
Purpose
Antiseptic
Uses
- helps reduce bacteria that potentially can cause disease
- helps prevent cross contamination by hand contact
- 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 or on open skin wounds
When Using This Product
- Keep out of eyes and mouth.
In case of contact with eyes, rinse eyes thoroughly with water
Stop Use And Ask A Doctor
if irritation or redness develops.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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.
Other Information
- avoid freezing and excessive heat above 40°C (104°F)
- may discolor certain fabrics
Inactive Ingredients
Water, Glycerin, Aloe Barbadensis Extract, Aminomethyl Propanol, Porpylene Glycol, Carbomer, Fragrance, Toopherol.
Package Labeling: 500Ml
Label (Label)
Package Labeling: 1000Ml
Label2 (Label2)
* Please review the disclaimer below.
