Active Ingredient
Alcohol 80%v/v
Gelmex Black
FDA Label NDC 80308-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Grupo Siller Ingenier�a Construcci�n Y Materiales, S.a. De C.v for the product Gelmex Black (NDC 80308-001). 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, purposes, uses, warnings, keep out of reach of children, dosage & administration, other, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Antiseptic
Uses
- Hand sanitizer to help reduce bacteria that potentially can cause disease.
- For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flamme.
Do not mix use with other household chemicals.
Do not use
- In children less than two months of age.
- On open skin wounds.
- Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes throughly with water.
When using this product:
Stop use and ask a doctor if irritation or rash occurs. These maybe sings of serious condition.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a poison control center right away.
Dosage & Administration
- Place enough product on hands to cover all surfaces. Rub hands together untill dry.
- Supervise children under 6 years age when using this product to avoid swallowing.
Other
- Store between 15-30°C (59-86°F)
- Avoid freezing and excesive heat above 400°C (104°F)
Inactive Ingredients
Glycerin, carbomer 940, aloe vera extract, purified water.
Image
Image Description (Gelmex)
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