Drugplain

Clobezin

clotrimazole and betamethasone dipropionate, zinc oxide · KIT · Skya Health, LLC

No Recall History
Plain English

Clobezin is a kit containing clotrimazole and betamethasone dipropionate, zinc oxide. Manufactured by Skya Health, LLC.

Key Facts

Brand Name
Clobezin
Generic Name
clotrimazole and betamethasone dipropionate, zinc oxide
NDC Code (Product)
73086-103
Manufacturer
Skya Health, LLC
Dosage Form
KIT
Marketing Status
Marketing Start
06/20/2025

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum in patients 17 years and older. Clotrimazole and Betamethasone Dipropionate Cream contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum in patients 17 years and older. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Treatment of tinea corporis or tinea cruris: Apply a thin film of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for one week. Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Do not use longer than 2 weeks. Treatment of tinea pedis: Gently massage a sufficient amount of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for two weeks. Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Do not use longer than 4 weeks. Clotrimazole and betamethasone dipropionate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes. Wash hands after each application. Tinea pedis: Apply a thin film to the affected skin areas twice a day for 2 weeks. Do not use longer than

Warnings

Warnings For external use only Allergy Alert: Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device applicator Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days in case of bleeding Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Skya Health, LLC. at 866-759-2669 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials common adverse reaction reported for clotrimazole and betamethasone dipropionate cream was paresthesia in 1.9% of patients. Adverse reactions reported at a frequency < 1% included rash, edema, and secondary infection. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following local adverse reactions have been reported with topical

Frequently Asked Questions

What is Clobezin used for?

Clobezin contains clotrimazole and betamethasone dipropionate, zinc oxide. It is a kit taken as directed. Consult your doctor for specific uses.

Is Clobezin a controlled substance?

Clobezin is not classified as a controlled substance by the DEA.

What is the generic name for Clobezin?

The generic name for Clobezin is clotrimazole and betamethasone dipropionate, zinc oxide. There are 1 other brand versions of clotrimazole and betamethasone dipropionate, zinc oxide.

What is the NDC code for Clobezin ?

The NDC (National Drug Code) for Clobezin is 73086-103, listed by Skya Health, LLC.

Product NDC

73086-103

Package NDC

73086-103-08

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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