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Distributed by FiteBac SkinCare, LLC, Marietta, Georgia 30064
Fitebac Hand Sanitizer
FDA Label NDC 13136-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fitebac Skincare, Llc for the product Fitebac Hand Sanitizer (NDC 13136-002). 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 other, active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Benzalkonium Chloride 0.1%
Purpose
Antimicrobial
Uses
- For hand sanitizing to decrease bacteria on the skin
Warnings
For external use only
Otc - When Using
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Use only a small, pea-sized amount as needed, which is enough to cover both your hands.
- Rub thoroughly over all surfaces of both hands
Storage And Handling
- Not intended to provide ongoing protection against new germ exposure
Inactive Ingredients
Cyclopentasiloxane, Dimethicone Crosspolymer, PPG-3 Benzyl Ether Ethylhexanoate
Questions, Comments, Side Effects Or Reordering
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