Otc - Active Ingredient
Miconazole Nitrate 2%
Aosorw Antifungal Cream
FDA Label NDC 85498-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spinestatus Llc for the product Aosorw Antifungal Cream (NDC 85498-011). 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, warnings, otc - ask doctor, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Indications & Usage
- For the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
- Relieves itching, burning, cracking, scaling, and discomfort caused by fungal infections.
Warnings
For external use only
Otc - Ask Doctor
before use if you have
- a condition that covers a large area of the body
- sensitive skin or any known allergies to the ingredients
Otc - Do Not Use
on children under 2 years of age except under the advice and supervision of a doctor.
Otc - When Using
avoid contact with eyes.
Otc - Stop Use
and ask a doctor if
- irritation occurs.
- there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch).
Otc - Pregnancy Or Breast Feeding
ask a health professional before use
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- wash 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 and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks.
- if conditions persist longer, ask a doctor.
- this product is not effective on the scalp or nails.
Other Safety Information
Store at 20°C to 25°C (68°F to 77°F).
Close the cap tightly after use.
Inactive Ingredient
Sophora Flavescens Root, Glycerin, Propylene Glycol, Peppermint Oil, Sodium Acrylate, Sodium Acryloyldimethyl Taurate, Isohexadecane, Polysorbate-80, Dimethicone, Triethanolamine
Otc - Questions
Contact us at [email protected]
* Please review the disclaimer below.
