X Prousa Antiseptic Hand Sanitizer Gel
FDA Label NDC 79490-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by X-prousa Llc for the product X Prousa Antiseptic Hand Sanitizer Gel (NDC 79490-000). 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, purpose, use, 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
Ethyl alcohol 72%
Purpose
Antiseptic
Use
- Hand sanitizer to help reduce bacteria on the skin that could cause disease
- Recommended for repeated use
Warnings
- For external use only
- Flammable, Keep away from heat or flame
Do Not Use
- Do not use on children less than 2 months of age
- Do not use on open skin wounds
When Using This Product
- keep out of eyes, ears and mouth.
- In case of contact with eyes, rinse eyes 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 15-30°C (59-86°F)
Avoid freezing and excessive heat above 40°C (104°°F)
Inactive Ingredients
Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Crylate Crosspolymer, Aminomethyl propanol, Vitamin E Acetate
Package Labeling::118Ml
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