Tri-soft Softening Solution
FDA Label NDC 44577-711
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clinical Therapeutic Solutions for the product Tri-soft Softening (NDC 44577-711). 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 tri-soft softening solution, active ingredient, purpose, uses:, warnings, keep out of reach of children, directions, other ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
BENZALKONIUM CHLORIDE (0.13 %)
Purpose
Antiseptic
Uses:
For antiseptic cleansing that will decrease bacteria on the skin without soap and water.
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.
Keep Out Of Reach Of Children
if swallowed, consult physician or poison control immediately
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.
Other Ingredients
Aqua (Deionized Water), Benzyl Alcohol, Phenylmercuric Nitrate, Polysorbate-20, SD-Alcohol 40B.
Other
Tri-Soft Softening Solution is a rapid-acting emulsifying agent combined with antiseptic properties.
It is specifically formulated for use on the skin prior to instrument reduction of hyperkeratotic lesions.
Tri-Soft Softening Solution 8Oz (44577-711-08)
Trisoft (Trisoft)
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