Tovet (emollient formulation) .5 mg/g

CLOBETASOL PROPIONATE · AEROSOL, FOAM · Medimetriks Pharmaceuticals, Inc.

No Recall History

Plain English

Tovet (emollient formulation) is a prescription aerosol, foam containing clobetasol propionate at .5 mg/g, taken topical. Manufactured by Medimetriks Pharmaceuticals, Inc..

Key Facts

Brand Name: Tovet (emollient formulation)
Generic Name: CLOBETASOL PROPIONATE
NDC Code (Product): 43538-952
Manufacturer: Medimetriks Pharmaceuticals, Inc.
Strength: .5 mg/g
Dosage Form: AEROSOL, FOAM
Route: TOPICAL
Marketing Status: HUMAN PRESCRIPTION DRUG
Application #: ANDA201402
Drug Class: Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]
Marketing Start: 02/01/2013

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,003 reports

pruritus809 reports

off label use647 reports

rash595 reports

psoriasis527 reports

fatigue486 reports

product use in unapproved indication482 reports

headache463 reports

nausea412 reports

diarrhoea410 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Tovet Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. Tovet Foam is a corticosteroid indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Apply a thin layer of Tovet Foam to the affected area(s) twice daily, morning and evening, for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved. The maximum weekly dose should not exceed 50 g or an amount greater than 21 capfuls per week. For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. Dispense a small amount of foam (about a capful) and gently massage the medication into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed. Tovet Foam is not for oral, ophthalmic, or intravaginal use. Avoid contact with the eyes. Avoid use on face, axillae, and groin, or if skin atrophy is present at the treatment site. Wash hands after each application. Tovet Foam is not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply Tovet Foam to the affected area(s) twice daily, morning and evening, for up to 2 consecutive weeks. The maximum weekly dose should not exceed 50 g. ( 2 ) Avoid use on face, axilla, and groin, or if skin atrophy is present at the treatment site. ( 2 )

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Effects on Endocrine System [see Warnings and Precautions (5.1) ] Ophthalmic Adverse Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions (incidence ≥ 1%) are application site atrophy and application site reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc., at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials 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 clinical practice. In controlled clinical trials involving 821 subjects exposed to clobetasol propionate foam, 0.05% (emulsion) and vehicle foam, the pooled incidence of local adverse reactions in trials for atopic dermatitis and psoriasis with clobetasol propionate foam, 0.05% (emulsion) was 1.9% for application site atrophy and 1.6% for application site reaction. Most local adverse events…

Frequently Asked Questions

What is Tovet (emollient formulation) used for?

Tovet (emollient formulation) contains CLOBETASOL PROPIONATE. It is a aerosol, foam taken topical. Consult your doctor for specific uses.

Is Tovet (emollient formulation) a controlled substance?

Tovet (emollient formulation) is not classified as a controlled substance by the DEA.

What is the generic name for Tovet (emollient formulation)?

The generic name for Tovet (emollient formulation) is CLOBETASOL PROPIONATE. There are 12 other brand versions of CLOBETASOL PROPIONATE.

What is the NDC code for Tovet (emollient formulation) .5 mg/g?

The NDC (National Drug Code) for Tovet (emollient formulation) .5 mg/g is 43538-952, listed by Medimetriks Pharmaceuticals, Inc..

Product NDC

43538-952

Package NDC

43538-952-10

Other Clobetasol Brands

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

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