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Product NDC Code | 84019-201 | ||||||||
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Drug Name | Fungal nail renewal |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LIQUID | ||||||||
Application Number | M005 | ||||||||
Labeler Name | Shengnan (Guangzhou) Cosmetics Co., LTD | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Undecenoic Acid 0.5%
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.Apply two drops each time, 2-3 times a day, do not rinse with cold water within 2 hours after use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Glycerin Propylene Glycol Otassium Iodide Menthol Camellia Sinensis Seed 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.RESTORES AND RENEWS HYDRATES DAMAGED NAILS
Purpose
Information about the drug product’s indications for use.Sterilizing
Spl product data elements
Usually a list of ingredients in a drug product.Fungal Nail Renewal Undecenoic Acid 11-HYDROXY-2-UNDECENOIC ACID 11-HYDROXY-2-UNDECENOIC ACID POTASSIUM IODIDE METAHOMOMENTHOL, (+/-)- CAMELLIA SINENSIS SEED OIL GLYCERIN PROPYLENE GLYCOL
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.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.Fungal Nail Renewal
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 on children under 2 years of age unless directed by a doctor.
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 section.
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.If swelling, blistering or other discomfort occurs,please stop using and consult doctor immediately. If symptoms have not been relieved after using for more than 7 days, please stop using and consult doctor immediately.
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.Avoid contact with eyes or mucous membranes. Do not apply to wounds or damaged skin. Do not use with other ointments, creams, sprays or liniments.
Storage and handling
Information about safe storage and handling of the drug product.Store in a cool dry place away from direct sunlight.
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.Do not use on children under 2 years of age unless directed by a doctor. For external use only. Avoid contact with the eyes. Keep out of reach of children section.
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