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Product NDC Code | 63029-592 | ||||
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Drug Name | Compound w maximum strength fast acting liquid |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
Application Number | M028 | ||||
Labeler Name | Medtech Products Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient
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 • using applicator, apply one drop at a time to sufficiently cover each wart • let dry • repeat this procedure once or twice daily 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 alcohol, camphor, castor oil, collodion, ether, ethylcellulose, hypophosphorous acid, menthol, polysorbate 80
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.Use for the removal of common and plantar warts the common wart is easily recognized by the rough “cauliflower-like” appearance of the surface 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 Salicylic acid 17% w/w............................................... Wart remover
Spl product data elements
Usually a list of ingredients in a drug product.Compound W Maximum Strength Fast Acting Liquid salicylic acid SALICYLIC ACID SALICYLIC ACID ALCOHOL CAMPHOR, (-)- CASTOR OIL LYTTA VESICATORIA ETHER ETHYLCELLULOSES HYPOPHOSPHOROUS ACID MENTHOL, (+)- POLYSORBATE 80
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 CompoundW Salicylic Acid Liquid NetWT 0.31 fl oz (9mL) PRINCIPAL DISPLAY PANEL CompoundW Salicylic Acid Liquid NetWT 0.31 fl oz (9mL)
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.Compound W ® Salicylic Acid LIQUID NET WT 0.31 FL OZ (9 mL) Drug Facts
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 skin or on any area that is infected or reddened on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes if you have diabetes or poor blood circulation
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, get medical help or contact a Poison Control Center (1-800-222-1222) 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 at room temperature avoid excessive heat 37C (99F) skin discoloration may occur during or after use wipe the rim of the bottle with a paper towel between uses
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-443-4908 Compoundw.com
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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes avoid inhaling vapors Cap bottle tightly and store at room temperature away from heat
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 . Flammable. Keep aware from fire and flame. Do not use on irritated skin or on any area that is infected or reddened on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes if you have diabetes or poor blood circulation When using this product avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes avoid inhaling vapors Cap bottle tightly and store at room temperature away from heat Stop use and ask a doctor if discomfort persists. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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