Lasolex Al Liquid
FDA Label NDC 59088-238
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 Al (NDC 59088-238). 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.
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 or there is no improvement within 4 weeks for athlete's foot and ringworm, or 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 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 Room Temperature]
- Do not use if package is damaged
- Protect from freezing and excessive heat
- Keep container tightly closed.
Inactive Ingredient
Inactive ingredients Acrylamide, Argania Spinosa (Argan) Kernel Oil, Benzyl Alcohol, Dimethyl Sulfoxide, dl-Alpha-Tocopheryl Acetate, Ethoxydiglycol, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-8, Polysorbate 80, Propylene Glycol, Sorbitan oleate.
Other
Manufactured by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free:
1-877-921-7873
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