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Product NDC Code | 10107-240 | ||||
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Drug Name | Cornstick |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | STICK | ||||
RxCUI drug identifier | 251407, 2043247 |
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Application Number | M030 | ||||
Labeler Name | Balassa Laboratories Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Salicylic acid 40% (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 and dry thoroughly keeping the product off the surrounding skin, apply thin layer of product to the corn or callus cover affected area with a clean bandage repeat this procedure every 48 hours as needed for up to 14 days (until the corn or callus is removed) may soak corn in warm water for 5 minutes to assist in removal
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Castor oil, D&C green 6, D&C violet 2, D&C yellow 11, menthol, paraffin, rosin, yellow wax
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 removal of corns and calluses. relieves pain by removing corns and calluses.
Purpose
Information about the drug product’s indications for use.Purpose Corn and Callus Remover
Spl product data elements
Usually a list of ingredients in a drug product.CornStick Salicylic Acid CASTOR OIL MENTHOL YELLOW WAX PARAFFIN ROSIN D&C GREEN NO. 6 D&C VIOLET NO. 2 D&C YELLOW NO. 11 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 - 5.1 g Tube in Carton MAXIMUM STRENGTH SALICYLIC ACID Removes Corns and Calluses! Corn STICK ® Solid-Stick Corn Remover and Callus Remover Relieves Pain by Removing Corns and Calluses Easy to Use Goes On Dry! NET WT 0.2 OZ (5.1g) 10107-240-02 CornStick Carton
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.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 if you are diabetic if you have poor circulation on irritated skin or any area that is infected or reddened
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 and pets. If swallowed, get medical help or contact a Poison Control Center right away.
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 occurs or condition persists
Storage and handling
Information about safe storage and handling of the drug product.Other Information Replace cap when finished and store at room temperature
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 if you are diabetic if you have poor circulation on irritated skin or any area that is infected or reddened Stop use and ask a doctor if discomfort occurs or condition persists Keep out of reach of children and pets. 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