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Product NDC Code | 62858-101 | ||||
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Drug Name | Nail renew |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 313423 | ||||
Application Number | M005 | ||||
Labeler Name | Nailrenew Corp | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT TOLNAFTATE 1.0%
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 affected area with soap and warm water and dry thoroughly. Apply 2-3 drops twice daily (morning & evening) to affected areas; especially around free edges of nails (under tips) and cuticles and the space around the toes. Allow solution to soak into nail or skin. This product is not effective on scalp or hair. Application to adjacent nails is recommended to prevent the spread of the infection. Keep affected areas clean and dry throughout the day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water (Aqua), PEG-8, Glyceryl Stearate, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Propylene Glycol, Aloe Barbadensis Leaf Juce, Coco-betaine, Octoxynol-9, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethylcellulose, Imidazolidinyl Urea, Benzyl Alcohol, Propylparaben, Triethanolamine
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 Helps cure most fungal nail and skin infections, including Tinea Corporis (Ringworm) and Tinea Pedis (Athlete's Foot). Effectively relieves itching, burning, cracking and scaling accompanying the above conditions.
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 RENEW TOLNAFTATE WATER POLYETHYLENE GLYCOL 400 GLYCERYL MONOSTEARATE CETOSTEARYL ALCOHOL CETETH-20 PHOSPHATE DIHEXADECYL PHOSPHATE PROPYLENE GLYCOL ALOE VERA LEAF COCO-BETAINE OCTOXYNOL-9 CETYL ALCOHOL STEARYL ALCOHOL HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) IMIDUREA BENZYL ALCOHOL PROPYLPARABEN TROLAMINE TOLNAFTATE TOLNAFTATE
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.NailRenew_BottleLabel_Front NailRenew_BottleLabel_Back-1 NailRenew_BottleLabel_Back-2
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 UNLESS DIRECTED BY A DOCTOR. NEAR OR IN EYES, EARS OR MOUTH.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? EMAIL: [email protected]
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. In case of accidental ingestion contact a physician, emergency medical care facility or poison control center. Stop use and ask a physician if rash or irritation occurs.
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