FDA Label for Thera Antifungal Body

View Indications, Usage & Precautions

Thera Antifungal Body Product Label

The following document was submitted to the FDA by the labeler of this product Mckesson Medical-surgical 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.

Active Ingredient



Miconazole Nitrate 2.0%


Purpose



Antifungal


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Uses



  • for the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Warnings



For external use only

Do Not Use On



  • children under 2 years of age unless directed by a doctor

When Using This Product



  • avoid contact with eyes

Stop Use And Ask A Doctor If



  • for athlete's foot and ringworm - irritation occurs or if there is no improvement within 4 weeks
  • for jock itch - irritation occurs or if there is no improvement within 2 weeks.

Directions



  • Clean the affected area and dry thoroughly
  • Apply a thin layer of the product over affected area twice daily (morning and night) 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
  • For jock itch, use daily for 2 weeks
  • If condition persists longer, consult a doctor. This product is not effective on the scalp or nails

Other Information



  • Protect from freezing. Avoid excessive heat.

Inactive Ingredients



Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, SAFFLEXTM (Consisting of: Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate,Tocopheryl Acetate (Vitamin E)), Bisabolol, Carthamus Tinctorius (Safflower) Oleosomes, Lavender Ylang Fragrance, Nylon-12, Sodium Benzoate, Sodium Hyaluronate, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.

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