Thera Antifungal Body Powder
FDA Label NDC 68599-0207

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson Medical-surgical Inc. for the product Thera Antifungal Body (NDC 68599-0207). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children., uses, warnings, do not use on, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

* Please review the disclaimer below.