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Product NDC Code | 84713-103 | ||||
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Drug Name | Bluedot callus removers |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
RxCUI drug identifier | 240559 | ||||
Application Number | M030 | ||||
Labeler Name | CREST MEDICAL LIMITED | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each dosage unit) Salicylic acid 40% in a plaster vehicle
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 • Apply medicated bandage after 48 hours, remove medicated bandage • 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 Acrylic adhesive, Titanium dioxide, Ferric hydroxide
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 the removal of corns and calluses • Relieves pain by removing corns and calluses • Adhesive bandage holds the medicated pad in position
Purpose
Information about the drug product’s indications for use.Purposes Corn and calluses removal
Spl product data elements
Usually a list of ingredients in a drug product.BLUEDOT Callus Removers Salicylic acid SALICYLIC ACID SALICYLIC ACID TITANIUM DIOXIDE FERRIC HYDROXIDE
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.Packaging CallusRmvr-1
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
• Maximum Strength • Medicated • Safe & effective callus removal treatment • Extra thick pads to protect against friction & reduce pressure DISTRIBUTED BY: Crest Medical Ltd. 3 Chesford Grange, Warrington, Cheshire. WA1 4RQ. UK. www.crestmedical.co.uk MADE IN BULGARIA
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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-723-2465
Storage and handling
Information about safe storage and handling of the drug product.Other information Store between 0° to 40°C (32° to 104°F)
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 a diabetic • If you have poor blood circulation • On irritated skin or any area that is infected or reddened Stop use and ask a doctor if Discomfort lasts 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