Lasolex Ac Cream
FDA Label NDC 59088-239
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 Ac (NDC 59088-239). 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
Antifungal
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, chafing associated with jock itch, itchy, scaly skin between the toes, or itching, burning feet.
Warnings
For external use only.
Do Not Use
on children under 2 years of age unless directed by 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 there is no improvement 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.
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 the spaces between the toes; Wear well fitting, ventilated shoes, and change shoes and socks atleast 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 Room Temperature] • Do not use if package is damaged • Protect from
freezing and excessive heat • Keep container tightly closed.
Inacive Ingredients
Aleurites moluccana (Kukui) Seed Oil, Bisabolol, Butylene Glycol, Calcium Pantothenate, Caprylyl Glycol, Carthamus tinctorius (Safflower) Oleosomes, Carthamus tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Cetyl Phosphate, Chlorphenesin, Dimethyl Sulfoxide, Dimethicone, Dimethicone Crosspolymer, Disodium EDTA, dl-Alpha-Tocopheryl Acetate, Glycerin, Glyceryl Stearate, Maltodextrin, Niacinamide, PEG-100 Stearate, Pentylene Glycol, Phenoxyethanol, Pyridoxine Hydrochloride, Silica, Sodium Ascorbyl Phosphate, Sodium Hyaluronate, Sodium Hydroxide, Sodium Starch Octenylsuccinate, Stearyl Alcohol, Water, Xylitol, Zingiber officinale (Ginger) Root Extract.
For Questions Or Information
call toll-free: 1-877-921-7873.
Package Label.Principal Display Panel
Manufactured by:
PureTek Corporation
Panorama City, CA 91402
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