Indications and uses
For antiseptic cleansing that will decrease bacteria on the skin without soap and water.
TRI-SOFT SOFTENING SOLUTION
- Manufacturer
- Clinical Therapeutic Solutions
- Effective date
- 2023-11-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:58:55
Label at a glance#
ProductTRI-SOFT SOFTENING
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections
Dosage and administration
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.
Label contents#
Full prescribing information#
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)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1046593 | benzalkonium chloride 0.13 % Medicated Liquid Soap | PSN | 4 |
| 1046593 | benzalkonium chloride 1.3 MG/ML Medicated Liquid Soap | SCD | 4 |
| 1046593 | benzalkonium chloride 0.13 % Medicated Liquid Soap | SY | 4 |
| 1046593 | benzalkonium chloride 1.33 MG/ML Medicated Liquid Soap | SY | 4 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44577-711-08 | TRI-SOFT SOFTENING | 236.59 mL in 1 BOTTLE | SOLUTION | 236.59 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZALKONIUM CHLORIDE | ACTIVE INGREDIENT | F5UM2KM3W7 | 1 | |
| BENZALKONIUM | ACTIVE MOIETY | 7N6JUD5X6Y | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| PHENYLMERCURIC NITRATE | INACTIVE INGREDIENT | CG8692ZN14 | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- TRI-SOFT SOFTENING
- BENZALKONIUM CHLORIDE
- WATER
- BENZYL ALCOHOL
- PHENYLMERCURIC NITRATE
- POLYSORBATE 20
- ALCOHOL
- BENZALKONIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 44577-711 | 44577-711-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| PHENYLMERCURIC NITRATE | CG8692ZN14 | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SOLUTION / TOPICAL | 15 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / TOPICAL | 2 %w/w | ||
| PHENYLMERCURIC NITRATE | PHENYLMERCURIC NITRATE | CG8692ZN14 | SOLUTION / ORAL | 0.03 mg/1ml | ||
| PHENYLMERCURIC NITRATE | PHENYLMERCURIC NITRATE | CG8692ZN14 | SOLUTION / ORAL | 0.03 mg/1ml | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / TOPICAL | 2 %w/w | ||
| PHENYLMERCURIC NITRATE | PHENYLMERCURIC NITRATE | CG8692ZN14 | SOLUTION / OPHTHALMIC | NA | ||
| PHENYLMERCURIC NITRATE | PHENYLMERCURIC NITRATE | CG8692ZN14 | SOLUTION / NASAL | 2 mg | ||
| PHENYLMERCURIC NITRATE | PHENYLMERCURIC NITRATE | CG8692ZN14 | SOLUTION / NASAL | 2 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| PHENYLMERCURIC NITRATE | PHENYLMERCURIC NITRATE | CG8692ZN14 | SOLUTION / OPHTHALMIC | NA | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SOLUTION / TOPICAL | 15 %w/w |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TRI-SOFT SOFTENING | BENZALKONIUM CHLORIDE | Clinical Therapeutic Solutions | 3d2bd5ab-5288-4d7d-b9e6-1b737a791bdb | 2023-11-05 | Warnings | 44577-711-08 44577-711 44577071108 0973c7d8-bd6d-e83b-e063-6294a90acf55 3d2bd5ab-5288-4d7d-b9e6-1b737a791bdb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.