OVACE Plus 100 mg/mL

SULFACETAMIDE SODIUM · SHAMPOO · Mission Pharmacal Company

No Recall History

Plain English

Ovace Plus is a prescription shampoo containing sulfacetamide sodium used to treat seborrheic dermatitis and other scalp conditions. You apply it topically to the affected areas of your scalp as directed by your healthcare provider.

Key Facts

Brand Name: OVACE Plus
Generic Name: SULFACETAMIDE SODIUM
NDC Code (Product): 0178-0485
Manufacturer: Mission Pharmacal Company
Strength: 100 mg/mL
Dosage Form: SHAMPOO
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 hypersensitivity65 reports

drug ineffective55 reports

nausea36 reports

dyspnoea31 reports

off label use31 reports

pain30 reports

headache29 reports

rash27 reports

weight decreased25 reports

fatigue24 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 OVACE Plus used for?

Is OVACE Plus a controlled substance?

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

What is the generic name for OVACE Plus?

The generic name for OVACE Plus is SULFACETAMIDE SODIUM. There are 11 other brand versions of SULFACETAMIDE SODIUM.

What is the NDC code for OVACE Plus 100 mg/mL?

The NDC (National Drug Code) for OVACE Plus 100 mg/mL is 0178-0485, listed by Mission Pharmacal Company.

Product NDC

0178-0485

Package NDC

0178-0485-04

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)