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| Product NDC Code | 73469-0644 | ||||
|---|---|---|---|---|---|
| Drug Name | Scholls wellness company llc duragel callus remover |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | DISC | ||||
| RxCUI drug identifier | 240559 | ||||
| Application Number | M030 | ||||
| Labeler Name | Scholls Wellness Company LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Active Ingredient Purpose Salicylic Acid 40%........ Callus remover
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 Directions wash affected area and dry thoroughly if necessary, cut medicated disc to fit callus apply medicated disc with sticky side adhering to skin cover medicated disc with enclosed cushion after 48 hours, remove medicated disc repeat procedure every 48 hours as needed for up to 14 days (until callus is removed) may soak callus 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 Inactive ingredients antioxidant (CAS 991-84-4), iron oxides, mineral oil, petroleum hydrocarbon resin, silicon dioxide, synthetic polyisoprene rubber, talc
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 Uses for the removal of calluses relieves pain by removing calluses
Purpose
Information about the drug product’s indications for use.Purpose Callus remover
Spl product data elements
Usually a list of ingredients in a drug product.Scholls Wellness Company LLC Duragel Callus Remover Salicylic Acid ANTIOXIDANT GS BROWN IRON OXIDE MINERAL OIL SILICON DIOXIDE SALICYLIC ACID SALICYLIC ACID TALC
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.Duragel Callus Remover
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 Drug Facts
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.Stop use and ask a doctor Stop use and ask a doctor if discomfort lasts
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 if you have poor blood 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. 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 Other information store between 20ºC to 25ºC (68º to 77ºF). Protect from excessive heat (temperatures above 40ºC (104ºF
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Questions? 1-866-360-3226
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 Warnings For external use only
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