FDA Label for Tri-soft Softening

View Indications, Usage & Precautions

Tri-soft Softening Product Label

The following document was submitted to the FDA by the labeler of this product Clinical Therapeutic Solutions. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Tri-Soft Softening Solution





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)




* Please review the disclaimer below.