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Product NDC Code | 55758-442 | ||||
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Drug Name | Kingskin saca callos |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 312881 | ||||
Application Number | M030 | ||||
Labeler Name | Pharmadel | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient & Purpose Salicylic acid 17% w/v.................. corn and callus remover Active ingredient Purpose Clotrimazole 1% Antifungal
Clotrimazole 1% | Antifungal |
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 a small amount at a time with applicator to sufficiently cover each corn/callus let dry repeat this procedure once or twice daily as needed up to 14 days (until corn/callus is removed) may soak corn/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 alcohol, camphor, ether
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
Purpose
Information about the drug product’s indications for use.Active ingredient Purpose Clotrimazole 1% Antifungal
Clotrimazole 1% | Antifungal |
Spl product data elements
Usually a list of ingredients in a drug product.Kingskin Saca Callos Salicylic acid CAMPHOR (SYNTHETIC) ETHER SALICYLIC ACID SALICYLIC ACID ALCOHOL
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 KingsKin Saca callos PDP
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
Other information cap bottle tightly and store at room temperature away from heat do not use if seal over cap is torn or missing
Distributed by/ Distribuido por: PHARMADEL LLC New Castle, DE 19720 • www.pharmadel.com +1-866-359-3478 Made in India / Hecho en India
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 this product on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation
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. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? +1-866-359-3478 (M-F) 9AM-5PM EST or www.pharmadel.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 podiatrist if discomfort 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 if it gets into the eye, flush with water for 15 minutes avoid inhaling vapors
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or lactating consult a doctor before using this product.
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. Do not use this product on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation When using this product if it gets into the eye, flush with water for 15 minutes avoid inhaling vapors Stop use and ask a doctor or podiatrist if discomfort persists If pregnant or lactating consult a doctor before using this product. KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
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