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Product NDC Code | 49283-025 | ||||
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Drug Name | Undecylenic acid |
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Type | Generic | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 998329 | ||||
Application Number | M005 | ||||
Labeler Name | Chemco Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Undecylenic Acid 25%
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: Wash affected area and dry thoroughly. Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily or as directed by a doctor. Supervise children in the use of this product. For athlete’s foot, pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete’s foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Isopropyl Alcohol, Water (Aqua), Tocopheryl Acetate, DMDM Hydantoin, Melaleuca Alternifolia Leaf 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: Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis). Relieves itching, scaling, cracking, burning, and redness.
Purpose
Information about the drug product’s indications for use.Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Undecylenic Acid Undecylenic Acid DMDM HYDANTOIN WATER ISOPROPYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE UNDECYLENIC ACID UNDECYLENIC ACID MELALEUCA ALTERNIFOLIA LEAF
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.PRONAIL FUNGUS KILLER FUNGUS KILLER
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.If swallowed, get medical help or contact a Poison Control Center right away.
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 or if there is no improvement within 4 weeks.
Safe handling warning
Safe Handling WarningEXTREMELY FLAMMABLE: Keep away from fire or flame.
General precautions
Information about any special care to be exercised for safe and effective use of the drug.OTHER INFORMATION: Store at room temperature 15° - 30°C (59° - 86°F)
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.For external use only. Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with eyes. If contact occurs, rinse thoroughly with water
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