Lasolex Ag Gel
FDA Label NDC 59088-207
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Lasolex Ag (NDC 59088-207). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Miconazole Nitrate 2%
Purpose
Anti-Fungal
Uses
- For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
- For relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort
Warnings
For external use only. Not for opthalmic use.
Do Not Use
on children under 2 years of age unless directed by Doctor.
When Using This Product
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 right away.
Directions
● Wash the affected area and dry thoroughly.
● Apply a thin layer of the product 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; for jock itch, use daily for 2 weeks.
● If condition persists longer, consult a doctor.
● This product is not effective on the scalp or nails.
Other Information
Store at 20° to 25°C (68° to 77°F) [see USP Controlled RoomTemperature]. Avoid excessive heat. Do not use if package is damaged.
Inactive Ingredients:
Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Caprylyl Glycol, Dimethicone, Dimethyl Sulfoxide, Dimethicone Crosspolymer, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxyethylcellulose, PEG-4, Phenoxyethanol, Propylene Glycol, Sodium Hyaluronate.
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