TRI-SOFT SOFTENING- benzalkonium chloride solution

TRI-SOFT SOFTENING by

Drug Labeling and Warnings

TRI-SOFT SOFTENING by is a Otc medication manufactured, distributed, or labeled by Clinical Therapeutic Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

TRI-SOFT SOFTENING 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44577-711
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENYLMERCURIC NITRATE (UNII: CG8692ZN14)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44577-711-08	236.59 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/06/2012

Labeler - Clinical Therapeutic Solutions (078402750)