FDA Label for Cvs Pharmacy Anti-fungal Pen Maximum Strength

View Indications, Usage & Precautions

Cvs Pharmacy Anti-fungal Pen Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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.

Active Ingredient



Undecylenic Acid 25%


Purpose



Anti-fungal


Uses



For the cure of most:

  • ringworm (tinea corporis)
  • athlete’s foot (tinea pedis)
  • For the relief of:

    • itching
    • scaling
    • crackling
    • burning
    • redness
    • soreness
    • irritation and discomfort which may accompany these conditions

Warnings



For external use only


Otc - Ask Doctor



Ask a doctor before use on children under 2 years of age


Otc - Do Not Use



Do not use on diaper rash


Otc - When Using



When using this product avoid contact with the eyes


Otc - Stop Use



Stop use and ask 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



  • read all warnings and directions
  • use only as directed
  • clean the affected area with soap and water and dry thoroughly
  • remove cap from pen
  • twist the base of the pen, with brush pointing downward, until product dispenses
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
  • 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
  • intended for use by normally healthy adults only
  • persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor
  • supervise children in the use of this product
  • this product is not effective on the scalp or nails

Other Information



  • Store at 15°-30C° (59°-86°F)
  • Keep cap on pen when not in use

Inactive Ingredients



Isopropyl Palmitate, Propylparaben


Questions Or Comments?



1-800-526-FOOT (3668) Mon-Fri 9AM - 5 PM EST


Image Of Label And Carton



CVSAntifungalPenLabel.jpg


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