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| Product NDC Code | 80569-084 | ||||
|---|---|---|---|---|---|
| Drug Name | Flush maximum strength antifungal formula |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 998329 | ||||
| Application Number | M005 | ||||
| Labeler Name | Triple Point Group, LLC | ||||
| 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.Active Ingredient Undecylenic Acid 25% Purpose Anti-fungal
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 and dry affected area with soap and water and dry throughly. Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician. For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. For athlete's foot and ringworm. If Conditions persists for longer, consult a physician. Intended for use typically by healthy adults only. Persons under the age of 18, or those with highly sensitive or allergic skin should use only as directed by physician. This product is not meant to be applied directly to the Scalp or nails.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other ingredients: Cymbopogan Nardus (Citronella) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzygium Aromaticum (Clovebud) Oil, Tocopheryl Acetate (Vitamin E).
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 cure of most: • ringworm (tinea corporis) • athlete's foot (tinea pedis). For the relief of: • itching• scaling • cracking • burning • redness • soreness • irritation and discomforts which may accompany these conditions.
Purpose
Information about the drug product’s indications for use.Purpose Anti-fungal
Spl product data elements
Usually a list of ingredients in a drug product.FLUSH Maximum Strength Antifungal formula UNDECYLENIC ACID CITRONELLA OIL LAVENDER OIL TEA TREE OIL ALMOND OIL JOJOBA OIL CLOVE OIL .ALPHA.-TOCOPHEROL ACETATE UNDECYLENIC ACID UNDECYLENIC ACID
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.Package Labeling Bottle
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS:
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use on children under two years of age
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 diaper rash.
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. 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 there is no improvement within four weeks.
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 eyes.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, 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. Ask a doctor before use on children under two years of age DO NOT USE on diaper rash. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs there is no improvement within four weeks. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.
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