FDA Label for Flush Maximum Strength Antifungal Formula

View Indications, Usage & Precautions

Flush Maximum Strength Antifungal Formula Product Label

The following document was submitted to the FDA by the labeler of this product Triple Point Group, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts:




Active Ingredient



Undecylenic Acid 25%


Purpose



Anti-fungal


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. 


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.


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.

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).


Package Labeling




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