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  5. Label Information: Micocilen

FDA Label for Micocilen

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - DO NOT USE
    8. OTC - WHEN USING
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL - 29.5 ML TUBE CARTON

Micocilen Product Label

The following document was submitted to the FDA by the labeler of this product Arymar Inc.. 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.

Other



Drug Facts

Distributed by: Arymar Inc.
8004 NW 154 St. #343 Miami Lakes FL 33016


Active Ingredient



Undecylenic Acid 15%


Purpose



Antifungal


Uses



  • proven clinically effective in the treatment of most athletes foot (linea pedis) and ringworm (linea corporis)

Warnings



  • For external use only

Otc - Pregnancy Or Breast Feeding



If pregnant or breast feeding consult a healthcare professional before use


Otc - Do Not Use



Do not use on children under 2 years of age except under advice and supervision of a doctor

Use only as directed by a doctor on persons with highly sensitive skin


Otc - When Using



When using this product avoid contact with the eyes


Stop Use And Ask A Doctor If



  • irritation occurs
  • there is no improvement within 4 weeks

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.


Directions



  • wash the affected area and dry thoroughly
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product

Other Information



  • Keep tightly closed when not in use
  • Store away from excessive heat and cold

Inactive Ingredients



Purified Water, Cetyl Alcohol, Acrylate/Sodium Acryloyl Dimethyl Taurate Copolymer, Glycerl Monostearate, Caprylic Triglyceride, Polysorbate 20, Phenol, Salicylic Acid, Tea Tree Oil.


Principal Display Panel - 29.5 Ml Tube Carton



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