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| Product NDC Code | 76348-995 | ||||
|---|---|---|---|---|---|
| Drug Name | Nail renu |
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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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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 (morning and night)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients C12-15 Alkyl Benzoate, Camphor, Ceramide III, Cinnamonum 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 Amygdallus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzgium Aromatique (Clove) Bud Oil, Thymol, Tocopherol (Vitamin E), Trimethylpentanediol-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 Fungal nail and Skin infections including athlete's foot (tinea pedis) and ringworm (tinea corporis) Effectively relieves itching, burning, cracking and scaling associated with the above conditions. helps prevent most athlete's foot from coming back with daily use
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 Renu Tolnaftate 1% TOLNAFTATE TOLNAFTATE CERAMIDE 3 CAMPHOR (NATURAL) CLOVE OIL THYMOL CITRONELLA OIL CLOVE TEA TREE OIL CINNAMON BARK OIL TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) ALPHA-TOCOPHEROL HIPPOPHAE RHAMNOIDES SEED OIL HIPPOPHAE RHAMNOIDES FRUIT OIL OREGANO LEAF OIL LAVENDER OIL LIMONENE, (+)- ALKYL (C12-15) BENZOATE PINENE JOJOBA OIL DIETHYLENE GLYCOL MONOETHYL ETHER PEPPERMINT OIL OLIVE OIL ALMOND 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.Nail RENU LABEL ART AND NAIL RENU BOX ART NRFungal Label 2 NailRenu Box
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
Instructions for use
Information about safe handling and use of the drug product.Directions: clean the affected area and dry thoroughly apply a thin layer over the affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks. If condition lasts longer, ask a doctor to prevent athlete's foot, apply to the feet once or twice daily this product is not intended for/or effective on the scalp.
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 at 68º - 77º (20º - 25º C)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments 267-482-0866 www.nailrenu.com
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 and ask a doctor if irritation occurs there is no improvement within 4 weeks if swallowed, get medical help or contact a Poison Control Center right away.
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, nose, and mouth.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf Pregnant or breastfeeding ask a health professional before use.
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.
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