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| Product NDC Code | 70000-0329 | ||||
|---|---|---|---|---|---|
| Drug Name | Salicylic acid |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 312881 | ||||
| Application Number | M028 | ||||
| Labeler Name | LEADER/ Cardinal Health 110, 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 wash or soak the affected area, may soak wart in warm water for 5 minutes dry area thoroughly apply small amount of wart remover with applicator to sufficiently cover each wart let dry and 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 camphor, castor oil, ethanol, ethyl ether, nitrocellulose
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.Salicylic Acid Liquid Wart Remover PYROXYLIN CAMPHOR (NATURAL) CASTOR OIL 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 LEADER Maximum Strength Wart Remover Salicylic Acid 17% Fast acting Liquid Removes Common and Plantar Warts NET 0.31 FL OZ (9 mL) Leader_Liquid Wart Remover_53-012LD-01.jpg
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 supervision of a doctor or podiatrist 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 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 20°C to 30°C (68°F to 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 1-800-200-6313
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 discomforts 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 eyes, flush with water for 15 minutes avoid inhaling vapors
Safe handling warning
Safe Handling WarningFlammable keep away from fire or flame cap bottle tightly and store at room temperature away 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 or flame cap bottle tightly and store at room temperature away heat Do not use if you are a diabetic or have poor blood circulation, except under the supervision of a doctor or podiatrist 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 When using this product avoid contact with eyes. If product gets into the eyes, flush with water for 15 minutes avoid inhaling vapors Stop use and ask a doctor if discomforts persists. 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