Luzu Cream
Name: Luzu Cream
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies to evaluate the carcinogenic potential of Luzu Cream, 1% have not been conducted.
Luliconazole revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster lung cell chromosomal aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus test).
In a fertility study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered prior to and during mating and through early pregnancy. Treatment-related effects on reproductive function were noted in females (decreased live embryos and decreased corpus luteum) at 5 and 25 mg/kg/day and males (decreased sperm counts) at 25 mg/kg/day. No-treatment related effects on fertility or reproductive function were noted at 1 mg/kg/day (0.1× MRHD based on BSA comparisons).
Patient Package Insert
LUZU (loo-zoo) (luliconazole) Cream, 1%
| Important information: Luzu Cream is for use on skin only. Do not get Luzu Cream near or in your eyes, mouth or vagina. |
What is Luzu Cream?
Luzu Cream is a prescription medicine used on the skin (topical) to treat athlete's foot that is between the toes (interdigital tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) in people 18 years of age and older.
It is not known if Luzu Cream is safe and effective in children.
What should I tell my doctor before using Luzu Cream?
Before using Luzu Cream, tell your doctor about all of your medical conditions, including if you:
• are pregnant or plan to become pregnant. It is not known if Luzu Cream will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if Luzu Cream passes into your breast milk.Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use Luzu Cream?
• Use Luzu Cream exactly as your doctor tells you to use it. • If you have athlete's foot (tinea pedis), apply a thin layer of Luzu Cream to the affected skin areas and to about 1 inch of the surrounding healthy skin once a day for 2 weeks. • If you have jock itch (tinea cruris) or ringworm (tinea corporis), apply Luzu Cream to the affected skin areas and to about 1 inch of the surrounding healthy skin once a day for 1 week. • Wash your hands after you apply Luzu Cream.What are the possible side effects of Luzu Cream?
Luzu Cream may cause skin reactions at the treatment site. Skin irritation may happen with Luzu Cream. Tell your doctor if you have any skin reactions on the areas of your skin treated with Luzu Cream.
These are not all the possible side effects of Luzu Cream.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Luzu Cream?
• Store Luzu Cream at room temperature between 68°F to 77°F (20°C to 25°C).Keep Luzu Cream and all medicines out of the reach of children.
General information about the safe and effective use of Luzu Cream
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or doctor for information about Luzu Cream that is written for health professionals. Do not use Luzu Cream for a condition for which it was not prescribed. Do not give Luzu Cream to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in Luzu Cream?
Active ingredient: luliconazole
Inactive ingredients: benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, isopropyl myristate, medium-chain triglycerides, methylparaben, polysorbate 60, propylene glycol, purified water, sorbitan monostearate.
Manufactured for:
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
By:
Valeant Pharmaceuticals International, Inc.
Laval, Quebec H7L 4A8 Canada
U.S. Patents 5,900,488; 8,980,931; 9,012,484; 9,199,977, and 9,453,006
Luzu is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
©Valeant Pharmaceuticals North America LLC
For more information, call 1-800-321-4576.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 02/2017 9438801 50105667B
PRINCIPAL DISPLAY PANEL - 60 gram Carton
NDC 99207-850-60
Rx only
LUZU®
(luliconazole) Cream, 1%
For Topical Use Only
Not for ophthalmic, oral, or intravaginal use
Keep Out of Reach of Children
Net. Wt. 60 g
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| Labeler - Valeant Pharmaceuticals North America LLC (182837492) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| DPT Laboratories, Ltd. | 832224690 | MANUFACTURE(99207-850) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Valeant Pharmaceuticals International, Inc | 245141858 | MANUFACTURE(99207-850) | |