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| Product NDC Code | 54633-712 | ||||
|---|---|---|---|---|---|
| Drug Name | Castellani paint 1.5% |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 199858, 309033 |
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| Application Number | part333A | ||||
| Labeler Name | The Podiatree Company | ||||
| 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 Phenol 1.5%
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 clean the affected area apply a small amount on the area one to three times daily
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Acetone, basic violet 14 (basic fuchsin), resorcinol, SD alcohol (13%), 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.Uses First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns
Purpose
Information about the drug product’s indications for use.Purpose First Aid Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Castellani Paint 1.5% phenol ACETONE RESORCINOL ALCOHOL WATER BASIC FUCHSIN PHENOL PHENOL
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 product label
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 in eyes with bandages on large areas of the body longer than one week unless directed by a doctor stop use and consult a doctor if condition persists in case of deep puncture wounds, animal bites, or serious burns, consult a doctor if known to be sensitive to any ingredients in this product
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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Suggestions? 1.855.763.8733 or visit us at www.thepodiatreecompany.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 or pharmacist if skin irritation or sensitivity develops or increases or if the condition persists or gets worse.
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 Check skin for sensitivity to phenol prior to application Use caution when applying as this product will stain skin and clothing
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at controlled 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 in eyes with bandages on large areas of the body longer than one week unless directed by a doctor stop use and consult a doctor if condition persists in case of deep puncture wounds, animal bites, or serious burns, consult a doctor if known to be sensitive to any ingredients in this product Stop use and ask a doctor or pharmacist if skin irritation or sensitivity develops or increases or if the condition persists or gets worse. When using this product Check skin for sensitivity to phenol prior to application Use caution when applying as this product will stain skin and clothing KEEP OUT OF REACH OF CHILDREN
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