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| Product NDC Code | 53329-410 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Mediplast |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PLASTER | ||||||
| RxCUI drug identifier | 240559, 1098584 |
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| Application Number | part358F | ||||||
| Labeler Name | Medline Industries, LP | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 40% Salicylic Acid
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 Wash affected area. May soak corn, callus or wart in warm water for 5 minutes. Dry area thoroughly. Cut pad to fit corn, callus or wart. Apply medicated pad to area. Remove medicated pad after 48 hours. Repeat procedure every 48 hours for up to 14 days for corn/callus removal and up to 12 weeks for warts, until the problem has cleared.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients O-Cresol, Lanolin, Myroxylon pereirae (Balsam Peru), Phenol, Talc, Terpineol Bandage: Flannel (99.7% cotton), Colophonium, Rubber Latex, 0.3% Polyurethane
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 the removal of corns and calluses Relieves pain by removing corns and calluses for the removal of common warts. The common wart is easily recognized by the rough ‘cauliflower-like’ appearance of the surface for the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.
Purpose
Information about the drug product’s indications for use.Purpose Corn, Callus, and Wart Remover
Spl product data elements
Usually a list of ingredients in a drug product.MediPlast salicylic acid PHENOL LANOLIN NATURAL LATEX RUBBER BALSAM PERU ROSIN TALC TERPINEOL SALICYLIC ACID SALICYLIC ACID ORTHOCRESOL
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.Package Labels Label V2 RE22PCC
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Indications and Usage
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.Manufacturing Information Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA www.curad.com 1-800-633-5463 REF: CUR01496 V2 RE22PCC
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do Not Use if you are diabetic or have poor blood circulation on irritated skin or on any area that is infected or reddened on moles, birthmarks, or warts with hair growing from them, genital warts, warts on the face, warts on mucous membranes such as warts inside the mouth, nose, anus, genitals or lips.
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 this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop using this product and see your doctor if discomfort persists for more than 72 hours
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. This product contains natural rubber, which may cause allergic reactions. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately. Stop using this product and see your doctor if discomfort persists for more than 72 hours Do Not Use if you are diabetic or have poor blood circulation on irritated skin or on any area that is infected or reddened on moles, birthmarks, or warts with hair growing from them, genital warts, warts on the face, warts on mucous membranes such as warts inside the mouth, nose, anus, genitals or lips.
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