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| Product NDC Code | 51142-595 | ||||
|---|---|---|---|---|---|
| Drug Name | Compound w |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 210140, 312880 |
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| Application Number | M028 | ||||
| Labeler Name | ASO LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Salicylic acid 17% w/w
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 by squeezing tube gently, 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, ethyl acetate, hydroxypropyl cellulose, hypophosphorous acid, isopropanol, nitrocellulose, polysorbate 80, water
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 on 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 Wart remover
Spl product data elements
Usually a list of ingredients in a drug product.Compound W Salicylic acid gel SALICYLIC ACID SALICYLIC ACID ETHYL ACETATE CAMPHOR (NATURAL) CASTOR OIL HYPOPHOSPHOROUS ACID POLYSORBATE 80 ALCOHOL HYDROXYPROPYL CELLULOSE (1600000 WAMW) ISOPROPYL ALCOHOL PYROXYLIN WATER
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 Compound W WART REMOVER Salicylic acid MAXIMUM STRENGTH FAST ACTING GEL + SHIELD EFFECTIVELY SHIELDS & REMOVES WARTS MADE FOR WARTS ON FEET No Drip Gel Maximum strength ProShield Patches Shields wart against rubbing GEL NET WT 0.25 oz (7 g) I 12 PROSHIELD PATCHES Part 2000057
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 Apply gel to wart and let dry (for approx. 5 minutes after application), before covering the wart with the ProShield Patch. store at room temperature avoid excessive heat 37C (99F) skin discoloration may accur during or after use wipe the tip of the tube 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 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 away 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 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