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Product NDC Code | 84369-087 | ||||
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Drug Name | Fungal nail patches |
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Type | Generic | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
RxCUI drug identifier | 2677690 | ||||
Application Number | M005 | ||||
Labeler Name | Shenzhen Rongxing Trading Co., Ltd. | ||||
Packages |
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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.Dosage and administration: For external use only.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Glycerin
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.Directions Of safe Use: For external use only Avoid direct contact with eyes Discontinue use if irritation occur Keep out of reach of childeren Store in a cool and dry place
Purpose
Information about the drug product’s indications for use.Product Use: For the Nail Renew
Spl product data elements
Usually a list of ingredients in a drug product.Fungal Nail Patches Fungal Nail Patches TOLNAFTATE TOLNAFTATE GLYCERIN
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.84369-087-01
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: Please keep outof reach of children.Do not Swallow.Please clean yourhandsbefore use to ensure the best results from the product Discontinue use if signs of irritation orrash occur Store in a cool and dry place.
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: Please keep outof reach of children.Do not Swallow.Please clean yourhandsbefore use to ensure the best results from the product Discontinue use if signs of irritation orrash occur Store in a cool and dry place.
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: Please keep outof reach of children.Do not Swallow.Please clean yourhandsbefore use to ensure the best results from the product Discontinue use if signs of irritation orrash occur Store in a cool and dry place.
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 section: Please keep outof reach of children.Do not Swallow.Please clean yourhandsbefore use to ensure the best results from the product Discontinue use if signs of irritation orrash occur Store in a cool and dry place.
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.Warning: Please keep outof reach of children.Do not Swallow.Please clean yourhandsbefore use to ensure the best results from the product Discontinue use if signs of irritation orrash occur Store in a cool and dry place.
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