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Product NDC Code | 83462-002 | ||||
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Drug Name | Tobcharm |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 1251008 | ||||
Application Number | part333C | ||||
Labeler Name | EUbizrival LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Undecylenic Acid 10%
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 feet thoroughly with warm water, and gently file thickened part of the fungal nail with a nail file until its flat apply layer of the liquid to the surface of the fungal nail and allow it to be absorbed into the nail. after the liquid has been absorbed, apply a layer of the cream to the infected parts of the nail repeat the process if necessary once a day
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients mineral oil, apricot kernel oil, tea tree oil, tocopherol, peppermint oil, camphor oil, jojoba oil, bergamot oil, lavender oil
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 Hinder fungal and bacterial growth, reduce itching, cleanse skin tissue.
Purpose
Information about the drug product’s indications for use.Purpose Anti-Fungal
Spl product data elements
Usually a list of ingredients in a drug product.Tobcharm Undecylenic Acid MINERAL OIL APRICOT KERNEL OIL TEA TREE OIL TOCOPHEROL PEPPERMINT OIL CAMPHOR OIL JOJOBA OIL BERGAMOT OIL LAVENDER OIL UNDECYLENIC ACID UNDECYLENIC 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.Product label image description
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.Other information Store at room temperature and our of direact sunlight. Skin discoloration may occur during or after use.
Questions ? Email at [email protected]
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 on irritated skin and any area that is infected or reddened if pregnant or if there is any allergic reaction to this product. When using this product avoid contact with eyes. Stop use and ask a doctor if if discomfort persists Keep out of reach of children. if product get into eyes, flush with water for 15 minutes 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