OvacePlus Plus 100 mg/g

SULFACETAMIDE SODIUM · CREAM · Mission Pharmacal Company

No Recall History

Plain English

Ovaceplus Plus is a topical cream containing sulfacetamide sodium that is applied to the skin to treat bacterial skin infections and certain inflammatory skin conditions. This prescription medication works by stopping the growth of bacteria on the skin.

Key Facts

Brand Name: OvacePlus Plus
Generic Name: SULFACETAMIDE SODIUM
NDC Code (Product): 0178-0495
Manufacturer: Mission Pharmacal Company
Strength: 100 mg/g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Marketing Start: 09/15/2011

Recall History

No Recall History

Side Effects Reported to FDA

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

drug hypersensitivity61 reports

drug ineffective37 reports

dyspnoea26 reports

headache25 reports

nausea24 reports

weight decreased22 reports

off label use21 reports

rash20 reports

fatigue18 reports

blood pressure increased16 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS: This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Seborrheic dermatitis including seborrhea sicca - Shake well before using. Apply to affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Repeat application as described for eight to ten days. As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of this product should be reinitiated as at the beginning of treatment. Secondary cutaneous bacterial infections - Shake well before using. Apply to affected areas twice daily for eight to ten days.

Warnings

WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF THE REACH OF CHILDREN.

Contraindications

CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

Adverse Reactions

ADVERSE REACTIONS: Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).

Frequently Asked Questions

What is OvacePlus Plus used for?

Is OvacePlus Plus a controlled substance?

OvacePlus Plus is not classified as a controlled substance by the DEA.

What is the generic name for OvacePlus Plus?

The generic name for OvacePlus Plus is SULFACETAMIDE SODIUM. There are 12 other brand versions of SULFACETAMIDE SODIUM.

What is the NDC code for OvacePlus Plus 100 mg/g?

The NDC (National Drug Code) for OvacePlus Plus 100 mg/g is 0178-0495, listed by Mission Pharmacal Company.

Product NDC

0178-0495

Package NDC

0178-0495-04

Other Sulfacetamide Brands

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

Data from openFDA · Public domain (CC0 1.0)