Active Ingredient
Benzalkonium Chloride 0.1%
Foaming Hand Sanitizer
FDA Label NDC 68878-119
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Theochem Laboratories Inc for the product Foaming Hand Sanitizer (NDC 68878-119). 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, purpose, uses, warnings, keep out of reach of children, directions:, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antimicrobial
Uses
For hand sanitizing to decrease bacteria on the skin.
Recommended for repeated use.
Warnings
For external use only.
When using this product, avoid contact with eyes. In case of eye contact, flush eyes with water.
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Pour contents into the Foaming Dispenser reservoir. For first use applications, pump dispenser a few time to prime. Pump a small amount of foam into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.
Other Information
Store below 110 °F (43 °C). May discolor certain fabrics or surfaces.
Inactive Ingredients
Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereteh-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, aloe barbadensis leaf juice.
Principal Display Panelfoaming Hand Sanitizer Net Contents: 3.785 Liters
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