Active Ingredient
Clotrimazole USP 1%
Antifungal Cream
FDA Label NDC 67777-727
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Antifungal (NDC 67777-727). 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, uses, warnings, stop use and ask a doctor if, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
• For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
• Relieves itching, scaling, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch and itching, burning feet
Warnings
• Do not use on children under 2 years of age unless directed by a doctor
• For external use only
• Avoid contact with eyes
Stop Use And Ask A Doctor If
• Irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor for athlete's foot and ringworm.
• Irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor for jock itch.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Directions
• Clean the affected area and dry thoroughly. Apply a thin layer 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. • If condition persists longer, consult a doctor. • This product is not effective on the scalp or nails.
Other Information
• Store at controlled room temperature 20°-25°C (68°-77°F)
• Tamper evident. Do not use if seal is damaged.
Inactive Ingredients
ceteth-20, cetostearyl alcohol, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, petrolatum
Label 1231-C
1231-c_in_master (1231 C In Master R250917 5)
Label 1233-C
1233-c_in_master (1233 C In Master R250917 6)
* Please review the disclaimer below.
