TRI-SOFT SOFTENING
TRI-SOFT SOFTENING is an FDA drug label for the active ingredient BENZALKONIUM CHLORIDE manufactured by Clinical Therapeutic Solutions administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231105.
Generic: BENZALKONIUM CHLORIDE
Manufacturer: Clinical Therapeutic Solutions
Product Type: HUMAN OTC DRUG
Route: TOPICAL
Dosage Form:
NDC: 44577-711
Application: 505G(a)(3)
Effective: 20231105
Active Ingredients: Active Ingredient BENZALKONIUM CHLORIDE (0.13 %)
Indications & Usage
Uses: For antiseptic cleansing that will decrease bacteria on the skin without soap and water.
Dosage & Administration
Directions Mix 1 part Tri-Soft Concentrate with water q. s. to 16 parts. Saturate cotton and place over hyperkeratotic tissues for 3 minutes before reduction or debridement.
Contraindications
Not available.
Warnings
Warnings For external use only. Do not use in the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and consult a physician if irritation or redness develops and persists for more than 72 hours. Do not bandage tightly. If pregnant or breast feeding, contact physician prior to use.
Adverse Reactions
Not available.
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