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| Product NDC Code | 44577-711 | ||||
|---|---|---|---|---|---|
| Drug Name | Tri-soft softening |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 1046593 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Clinical Therapeutic Solutions | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient BENZALKONIUM CHLORIDE (0.13 %)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients Aqua (Deionized Water), Benzyl Alcohol, Phenylmercuric Nitrate, Polysorbate-20, SD-Alcohol 40B.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses: For antiseptic cleansing that will decrease bacteria on the skin without soap and water.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.TRI-SOFT SOFTENING BENZALKONIUM CHLORIDE WATER BENZYL ALCOHOL PHENYLMERCURIC NITRATE POLYSORBATE 20 ALCOHOL BENZALKONIUM CHLORIDE BENZALKONIUM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.TRI-SOFT SOFTENING SOLUTION 8oz (44577-711-08) TRISOFT
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.TRI-SOFT SOFTENING SOLUTION
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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children if swallowed, consult physician or poison control immediately
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API