Clotrimazole and Betamethasone Dipropionate
These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM. CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE cream, for topical use Initial U.S. Approval: 1984
8d03b9ba-f7a8-4fbf-9be1-83d815c2be45
HUMAN PRESCRIPTION DRUG LABEL
Jul 19, 2023
NORTHSTAR RX LLC
DUNS: 830546433
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clotrimazole and Betamethasone Dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
Rx only
NDC 16714-496-02
Clotrimazole and Betamethasone Dipropionate Cream USP
1%/0.05%
ATTENTION PHARMACIST: Dispense with enclosed Patient Information Leaflet.
ATTENTION PATIENT: See Patient Information Leaflet before using this product.
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. NOT
RECOMMENDED
FOR PATIENTS UNDER THE AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER
DERMATITIS.
NORTHSTARX®
45 g
NONCLINICAL TOXICOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential of the combination of clotrimazole and betamethasone dipropionate or either component individually.
Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli) and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.
In a combined study of the effects of clotrimazole on fertility, embryofetal development, and postnatal development, male and female rats were dosed orally (diet admixture) with dose levels of 5, 10, 25, or 50 mg/kg/day from 10 weeks prior to mating until 4 weeks postpartum. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted.
Reproductive studies with betamethasone dipropionate conducted in rabbits at doses of 1.0 mg/kg/day by the intramuscular route and in mice up to 33 mg/kg/day by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species.
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% is a smooth white cream and supplied in 15-gram (NDC 16714-496-01) and 45-gram (NDC 16714-496-02) tubes; boxes of one.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
INFORMATION FOR PATIENTS SECTION
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform the patient of the following:
Pregnancy
Advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1)].
Lactation
Advise a woman to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clotrimazole and betamethasone dipropionate cream directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2)].
Important Administration Instructions
Inform the patient of the following:
- Use clotrimazole and betamethasone dipropionate cream as directed by the physician. It is for external use only.
- Avoid contact with the eyes, the mouth, or intravaginally.
- Advise patients to report any visual symptoms to their healthcare providers.
- Do not use clotrimazole and betamethasone dipropionate cream on the face or underarms.
- Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream per week.
- When using clotrimazole and betamethasone dipropionate cream in the groin area, patients should use the medication for 2 weeks only, and apply the cream sparingly. Patients should wear loose-fitting clothing. Notify the physician if the condition persists after 2 weeks.
- Do not use clotrimazole and betamethasone dipropionate cream for any disorder other than that for which it was prescribed.
- Do not bandage, cover or wrap the treatment area unless directed by the physician. Avoid use of clotrimazole and betamethasone dipropionate cream in the diaper area, as diapers or plastic pants may constitute occlusive dressing.
- Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use.
- This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify the physician if there is no improvement after 1 week of treatment for tinea cruris or tinea corporis, or after 2 weeks for tinea pedis.
SPL PATIENT PACKAGE INSERT SECTION
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Patient Information |
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This Patient Information has been approved by the U.S. Food and Drug Administration. |
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Important information: Clotrimazole and betamethasone dipropionate cream is for use on skin only. Do not use clotrimazole and betamethasone dipropionate cream in your eyes, mouth, or vagina. |
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What is clotrimazole and betamethasone dipropionate cream?
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Before using clotrimazole and betamethasone dipropionate cream, tell your healthcare provider about all your medical conditions, including if you:
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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. |
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How should I use clotrimazole and betamethasone dipropionate cream?
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What should I avoid while using clotrimazole and betamethasone dipropionate
cream? |
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What are the possible side effects of clotrimazole and betamethasone
dipropionate cream? *Clotrimazole and betamethasone dipropionate cream can pass through your skin. Too much clotrimazole and betamethasone dipropionate cream passing through your skin can cause your adrenal glands to stop working. Your healthcare provider may do blood tests to check for adrenal gland problems. *Vision problems. Topical corticosteroids may increase your chance of developing cataracts and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with clotrimazole and betamethasone dipropionate cream. |
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The most common side effects of clotrimazole and betamethasone dipropionate cream include burning, tingling, rash, swelling, and infections. |
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These are not all the possible side effects of clotrimazole and betamethasone dipropionate cream. |
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Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store clotrimazole and betamethasone dipropionate cream? |
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General information about the safe and effective use of clotrimazole and betamethasone dipropionate cream. |
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Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use clotrimazole and betamethasone dipropionate cream for a condition for which it was not prescribed. Do not give clotrimazole and betamethasone dipropionate cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about clotrimazole and betamethasone dipropionate cream that is written for health professionals. |
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What are the ingredients in clotrimazole and betamethasone dipropionate
cream? |
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For more information, contact Northstar RxLLC at 1-800-206-7821. |
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Manufactured for: Northstar RxLLC, Memphis, TN 38141. |
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Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761. |
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Revised: September 2019 20902-0919-3 47 |