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Product NDC Code | 36800-378 | ||||
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Drug Name | Salicylic acid |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
RxCUI drug identifier | 240559 | ||||
Application Number | M028 | ||||
Labeler Name | Topco Associates LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid 40%
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 wart in warm water for 5 minutes dry area thoroughly if necessary, cut medicated patch to fit wart apply the adhesive side of patch onto wart cover medicated patch with pad to conceal area repeat procedure every 48 hours as needed (until wart is removed) for up to 12 weeks
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol
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 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 Plantar wart remover
Spl product data elements
Usually a list of ingredients in a drug product.Salicylic Acid Medicated Plantar Wart Remover POLYVINYL ALCOHOL VINYL ACETATE HIGH DENSITY POLYETHYLENE SALICYLIC ACID SALICYLIC ACID
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.Principal Display Panel TopCare health MEDICATED Plantar Wart Remover SALICYLIC ACID 40% Cushions, Conceals & Protects While Removing Warts Maximum Strength Formula Without the Mess of Liquids 24 MEDICATED PATCHES 24 CUSHIONING PADS plantar
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you ahve diabetes poor blood circulation
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 on irritated, infected or reddened skin on genital warts and warts on the face on moles, birthmarks and warts with hair growing from them on mucous membranes
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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store between 15° and 30°C (59° and 86°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-888-423-0139
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 use and ask a doctor if discomfort persists.
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 on irritated, infected or reddened skin on genital warts and warts on the face on moles, birthmarks and warts with hair growing from them on mucous membranes Ask a doctor before use if you ahve diabetes poor blood circulation Stop use and ask a doctor if discomfort persists. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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