Active Ingredient
Benzalkonium chloride 0.13% w/v
Prime
FDA Label NDC 79382-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Industries Usa, Inc for the product Prime (NDC 79382-002). 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 active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, package label - principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antibacterial
Use
For handwashing to decrease bacteria on the skin
Warnings
For external use only
When using this product, avoid contact with eyes. In case of contact with eyes, flush with water.
Stop use and ask a doctor if irritation or redness develops.
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
Pump into hands & wet as needed. Lather vigorously for at least 20 seconds. Wash skin, rinse thoroughly and dry
Inactive Ingredients
Water, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone.
Package Label - Principal Display Panel
* Please review the disclaimer below.
