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Product NDC Code | 84222-002 | ||||||
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Drug Name | Nail lab fungomer nailelixir |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | OIL | ||||||
RxCUI drug identifier | 313423 | ||||||
Application Number | M005 | ||||||
Labeler Name | Foshan Miwei Cosmetics Co., Ltd. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Tolnaftate 1%
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: Soak your nails in warm water for 10-15 minutes. Gently dry the needed area using a clean paper towel. Use the nail file to remove the soft part of the nail. Apply a few drops of oil on the needed area using the pipette. Spread the liquid over the cuticles and nearby skin using the brush. Gently massage the solution into the needed area. Allow the solution to absorb for 10-1 5 minutes. Avoid contact with eyes and mouth. Repeat 3 times a day. Recommended to leave on overnight. Travel Pen: Rotate the top clockwise to dispense the solution. Designed for your convenience, making every trip easier.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Vitis Vinifera Seed Oil, Simmondsia Chinensis Seed Oil, Prunus Amygdalus Dulcis Oil, Argania Spinosa Kernel Oil, Melaleuca Alternifolia Leaf Oil, Tocopherol, Origanum Vulgare 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 For all caused by nail fungus Nail discoloration Nail thickening Nail splitting Nail crumbling
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.NAIL LAB FUNGOMER NAILELIXIR Tolnaftate 1% ARGAN OIL TEA TREE OIL TOLNAFTATE TOLNAFTATE GRAPE SEED OIL JOJOBA OIL TOCOPHEROL ALMOND OIL OREGANO LEAF OIL
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.box sticker
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 apply to broken or inflamed skin.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information: Store in a cool, dry place, away from direct sunlight. Ensure nail enhancement equipment is sterilized prior to each application. Utilize only uncontaminated and sanitized supplies. Maintain nails by keeping them neatly trimmed and devoid of any accumulated debris. Should any concerns arise, seek professional medical consultation. promptly.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Email: support @ nail-lab.co
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.Discontinue if irritation occurs.
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 and mouth. If contact occurs, rinse immediately. Test on a small skin area 24 hours before full use.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or nursing, seek medical advice before use.
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.Warnings External Use Only. Avoid contact with eyes and mouth. If contact occurs, rinse immediately. Test on a small skin area 24 hours before full use. Discontinue if irritation occurs. Keep out of reach of children. If pregnant or nursing, seek medical advice before use. Avoid mixing with other products. Check the expiry date. Do not apply to broken or inflamed skin.
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