Active Ingredient(S)
Alcohol 75% v/v
Germ Shark Antibacterial Hand Sanitizer
FDA Label NDC 75158-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Germ Shark, Llc for the product Germ Shark Antibacterial Hand Sanitizer (NDC 75158-001). 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, inactive ingredients, use(s), 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
Purpose
Antiseptic
Inactive Ingredients
Water 24.44%, Carbomer 0.20%, PEG-40 Hydrogenated Castor Oil 0.20%, Triethanolamine 0.16%.
Use(S)
Hand sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are are not available.
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
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.
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
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Package Labeling:75158-001-60
Label (Label)
Package Labeling:75158-001-50
Label2 (Label2)
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