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Product NDC Code | 56104-237 | ||||
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Drug Name | Wart remover gel |
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Type | Generic | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 312880 | ||||
Application Number | M028 | ||||
Labeler Name | Premier Brands of America Inc. | ||||
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 after washing affected area, soak wart in for 5 minutes in comfortably warm water dry area thoroughly gently squeeze a drop of gel from tube and apply to wart. Apply one drop at a time to sufficiently cover each wart let dry repeat this procedure once or twice daily (until wart is removed) for up to 12 weeks
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients camphor, castro oil, ethyl acetate, hydroxypropyl cellulose, hypophosphorous acid, isopropyl alcohol, nitrocellulose, polysorbate 80, SDA 3C ethyl 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.Use for the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. 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.Wart Remover Gel Wart Remover Gel CAMPHOR (NATURAL) ALCOHOL ETHYL ACETATE HYPOPHOSPHOROUS ACID HYDROXYPROPYL CELLULOSE (1600000 WAMW) POLYSORBATE 80 PYROXYLIN 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 Premier Maximum Strength Wart Remover Fast Acting Gel Removes common and plantar warts Convenient & easy No drip formula Safe & Effective Net Wt 0.25 OZ (7 g) Gel Wart tube
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.If discomforts persists if discomforts persists see your doctor or podiatrist Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist Do not use on moles, birthmarks and warts with hair growing from them mucous membranes such as nose, anus, genitals and lips irritated, infected or reddened skin genital warts and warts on the face When using this product if product gets into the eyes, flush with water for 15 minutes avoid inhaling vapors If discomforts persists if discomforts persists see your doctor or podiatrist Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do not use on moles, birthmarks and warts with hair growing from them mucous membranes such as nose, anus, genitals and lips irritated, infected or reddened skin genital warts and warts on the face When using this product if product gets into the eyes, flush with water for 15 minutes avoid inhaling vapors If discomforts persists if discomforts persists see your doctor or podiatrist Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 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 59°F to 86°F (15°C to 30°C)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? call 1-866-964-0939
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 if product gets into the eyes, flush with water for 15 minutes avoid inhaling vapors If discomforts persists if discomforts persists see your doctor or podiatrist Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Safe handling warning
Safe Handling Warning Flammable keep away from fire and flame Do not use if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist Do not use on moles, birthmarks and warts with hair growing from them mucous membranes such as nose, anus, genitals and lips irritated, infected or reddened skin genital warts and warts on the face When using this product if product gets into the eyes, flush with water for 15 minutes avoid inhaling vapors If discomforts persists if discomforts persists see your doctor or podiatrist Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist Do not use on moles, birthmarks and warts with hair growing from them mucous membranes such as nose, anus, genitals and lips irritated, infected or reddened skin genital warts and warts on the face When using this product if product gets into the eyes, flush with water for 15 minutes avoid inhaling vapors If discomforts persists if discomforts persists see your doctor or podiatrist Keep out of 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