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Product NDC Code | 55758-409 | ||||
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Drug Name | Kingskin |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 312881 | ||||
Application Number | M028 | ||||
Labeler Name | Pharmadel LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient and Purpose Active ingredient Purpose Salicylic acid 17% w/w................................... Wart remover
Salicylic acid 17% 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 dry area thoroughly apply one drop at a time with applicator to sufficiently cover each wart let dry repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks
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.Use For the removal of common warts. The common wart is easily recognized by the rough “cauliflower-like” appearance of the surface.
Purpose
Information about the drug product’s indications for use.Active ingredient Purpose Salicylic acid 17% w/w................................... Wart remover
Salicylic acid 17% w/w................................... |
Spl product data elements
Usually a list of ingredients in a drug product.Kingskin Salicylic acid ALCOHOL ETHER CAMPHOR (SYNTHETIC) 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 PDP kingskin
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 For external use only. FLAMMABLE: keep away from fire or flame. on irritated skin on any area that is infected or reddened if you are a diabetic if you have poor blood circulation on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face on mucous membranes
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 accidental ingestion occurs, 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 store at room temperature away from heat do not use if seal over cap is torn or missing.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-866-359-3478 (M-F) 9 AM -5 PM 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 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 cap bottle tightly if product gets into the eye, flush with water for 15 minutes avoid inhaling vapors
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 Do not use For external use only. FLAMMABLE: keep away from fire or flame. on irritated skin on any area that is infected or reddened if you are a diabetic if you have poor blood circulation on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face on mucous membranes When using this product cap bottle tightly if product gets into the eye, flush with water for 15 minutes avoid inhaling vapors Stop use and ask a doctor if discomfort persists. KEEP OUT OF REACH OF CHILDREN. If accidental ingestion occurs, 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