Active Ingredient
Ketoconazole 1%
Ketoconclear Cream
FDA Label NDC 87976-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Shunfei Network Technology Co., Ltd. for the product Ketoconclear Cream (NDC 87976-002). 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, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Use
Treats:
• Athlete's Foot
• Jock Itch
• Ringworm
Helps relieve itching, burning, and discomfort associated with fungal skin conditions.
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 the eyes
Stop use and ask a doctor if
• irritation occurs
• there is no improvement within 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
When Using
When using this product:
• avoid contact with the eyes
Stop Use
Stop use and ask a doctor if:
• irritation occurs
• there is no improvement within 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch
Ask Doctor
Ask a doctor if irritation occurs or symptoms do not improve within the recommended time period.
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
Clean and dry affected area.<br>• Apply a thin layer once daily or as directed by a doctor.
Other Information
Store at 20° to 25°C (68° to 77°F).
Inactive Ingredients
Water, Propylene Glycol, Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60, Sodium Sulfite, Polysorbate 80, Isopropyl Myristate.
Questions
1-858-905-0218
Principal Display Panel
Pack (Pack)
87976-002
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