Other
Drug Facts
Antifungal Body Cream
FDA Label NDC 68599-0206
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 for the product Antifungal Body (NDC 68599-0206). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Miconazole Nitrate 2%
Otc - Purpose
Purpose
Antifungal
Indications & Usage
Uses
- for treatment of most 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
- for treatment ofsuperficial skin infections caused by yeast (Candida albicans)
Warnings
Warnings
- For External use only.
- Do not get into eyes
- irritation occurs or if there is no improvement within 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch.
- children under 2 years of age unless directed by a doctor
- diaper rash
When using this product
Stop use and ask a doctor if
Do not use on
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.
Dosage & Administration
Directions
- Clean the affected area and dry thoroughly
- Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician
- Supervise children in the use of this product
- Pay special attention to the spaces between toes
- Wear well-fitting, ventilated shoes and change shoes and socksat least once daily
- Use daily for 4 weeks
- Use daily for 2 weeks. If condition persists longer, consult a doctor.
Athlete’s foot
Athlete’s foot and ringworm
Jock itch
This product is not effective on scalp or nails.
Inactive Ingredient
Inactive ingredients
Isopropyl Palmitate, Glyceryl Stearate, PEG 100 Stearate, Cyclopentasiloxane, Cetearyl Alcohol, Propylene Glycol, Polyquaternium-37, Propylene Glycol Dicaprylate/Dicaprate, PPG-1 Trideceth-6, Aloe Barbadensis Leaf Juice, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopherol Acetate (Vitamin E), Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Triethanolamine, DMDM Hydantoin, Iodopropynyl Butylcarbamate
Package Label.Principal Display Panel
McKesson Thera Antifungal Body Cream
Helps treat the most common fungal infections including athlete's foot, jock itch and ringworm.
Single Patient Use
Therapy [for the skin]
Net Contents 4 fl oz (118ml)
MFR# 53-AF4
* Please review the disclaimer below.
