Otc - Active Ingredient
Hydrocortisone 1%
Miconazole Nitrate 2%
Menthol 0.5%
Kvglads Miconazole Nitrate 2% Antifungal Cream
FDA Label NDC 88029-002
12 label sections · Submitted to the FDA by Jiangxi Guchong Biotechnology Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Guchong Biotechnology Co., Ltd. for the product Kvglads Miconazole Nitrate 2% Antifungal (NDC 88029-002). 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 otc - active ingredient, otc - purpose, indications & usage, dosage & administration, inactive ingredient, warnings, otc - do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Anti-Itch
Indications & Usage
■ For treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis), and superficial skin yeast infections (Candida albicans).
■ For temporary relief of itching, scaling, cracking, burning, redness, irritation and discomfort associated with these fungal skin conditions.
Dosage & Administration
Directions
■ Wash the affected area and dry thoroughly.
■ Apply a thin layer of cream over affected area twice daily (morning and night).
■ For athlete’s foot and ringworm: use daily for 4 weeks.
■ For jock itch: use daily for 2 weeks.
■ For athlete’s foot: pay special attention to spaces between toes; wear well-fitting ventilated shoes, change socks daily.
Inactive Ingredient
Petrolatum, Sorbitol, Sorbitan Stearate, Methylparaben, PEG-60 Sorbitan Stearate, Polyacrylamide, C13-14 Isoparaffin, Borneol, Laureth-6, Purified Water.
Warnings
For external use only.
Otc - Do Not Use
■ On children under 2 years of age unless directed by a doctor. ■ For diaper rash. ■ On scalp or nails.
Otc - When Using
■ Avoid contact with eyes. ■ Do not use more than 7 days unless directed by a doctor. ■ This product is not effective on the scalp or nails.
Otc - Stop Use
■ Condition worsens, symptoms persist more than 7 days or clear up and recur within a few days. ■ Irritation occurs. ■ No improvement within 4 weeks for athlete’s foot / ringworm, or within 2 weeks for jock itch.
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.
Other Safety Information
■ Store at 59°F–86°F (15°C–30°C). ■ Do not freeze.
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