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| Product NDC Code | 76348-990 | ||||
|---|---|---|---|---|---|
| Drug Name | Flawless nails |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 313423 | ||||
| Application Number | M005 | ||||
| Labeler Name | RENU LABORATORIES, INC. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Tolnaftate
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 clean the affected area and dry thoroughly apply a thin layer over the affected area twice daily supervise children in the use of this product for athletes foot pay special attention to the spaces between toes use daily for 4 weeks
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients C12-15 Alkyl Benzoate, Camphor, Ceramide III, Cinnamonium Zeylanicum (Cinnamon Bark) Oil, Cymbopogon Nardus (Citronella) Oil, Ethoxydiglycol, Eugenia Caryophyllum (Clove Bud) Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Lavandula Angustifolia (Lavender) Oil, Limonene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive Pomace) Oil, Oreganum Vulgare (Oregano) Leaf Oil, Pinene, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzgium Aromaticum (Clove Bud) Oil, Thymol, Tocopherol Acetate, Trimethyl-Adipic Acid Copolymer.
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 proven clinically to cure most: athlete's foot (tinea pedis) ringworm (tinea corporis) Effectively soothes and relieves: itching burning cracking helps prevent most athlete's foot from coming back with daily use
Purpose
Information about the drug product’s indications for use.Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.FLAWLESS NAILS Tolnaftate CAMPHOR (NATURAL) CINNAMON BARK OIL HIPPOPHAE RHAMNOIDES FRUIT OIL TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) PINENE ALMOND OIL PEPPERMINT OIL .ALPHA.-TOCOPHEROL ACETATE TOLNAFTATE TOLNAFTATE CLOVE LAVENDER OIL LIMONENE, (+)- ALKYL (C12-15) BENZOATE TEA TREE OIL HIPPOPHAE RHAMNOIDES SEED OIL DIETHYLENE GLYCOL MONOETHYL ETHER CITRONELLA OIL CERAMIDE 3 OLIVE OIL OREGANO LEAF OIL JOJOBA OIL CLOVE OIL THYMOL
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.FLAWLESS NAILS LABEL AND FLAWLESS NAILS BOX FLAWLESS NAILS BOX FLAWLESS NAIL LABEL
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.No major changes in Directions. We forgot to save the section and had to retype it. Only changes made in Dosage were the removal of bullets and unapproved punctuation.
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. 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 68° - 77°
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.MyFlawlessNails LLC Fairfield, CT 06824 www.MyFlawlessNails.com
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, avoid contact with the eyes
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 children under 2 years of age unless directed by a doctor When using this product avoid contact with the eyes Stop use and ask a doctor if there is no improvement within 4 weeks Keep out of reach of children. Get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor When using this product, avoid contact with the eyes Keep out of reach of children. 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