Otc - Active Ingredient
Benzalkonium chloride 0.13%
Hand Sanitizer
FDA Label NDC 19392-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Humphreyline for the product Hand Sanitizer (NDC 19392-120). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, nonalcohol, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antimicrobial
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
Hand sanitizer to help reduce bacteria on the skin
Warnings
For external use only
Do not use in or near the eyes
Stop use and ask a doctor if irritation or rash appears and lasts
Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away
Dosage & Administration
Wet hands thoroughly with product and allow to dry without wiping
Inactive Ingredient
Water, cetrimonium chloride, citric acid, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, laurtrimonium chloride
Nonalcohol
Nonalcohol (Nonalcohol)
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