FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
OVACE ® Plus Cream 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.
History
There is currently no drug history available for this drug.
Other Information
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Each gram of OVACE
® Plus Cream (sodium sulfacetamide 10% w/w) contains 100 mg of sodium sulfacetamide in a vehicle consisting of benzyl alcohol, butylparaben, C13-14 isoparaffin, caprylic/capric triglyceride, cetyl alcohol, dimethicone, disodium EDTA, ethylparaben, glycerin, glyceryl stearate, laureth-7, methylparaben, PEG-100 stearate, phenoxyethanol, polyacrylamine, propylparaben, sodium thiosulfate, water and zinc oxide.
Sodium sulfacetamide is C
8H
9N
2NaO
3S·H
2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Sources
Ovaceplus Plus Manufacturers
-
Mission Pharmacal Company
Ovaceplus Plus | Mission Pharmacal Company
Seborrheic dermatitis including seborrhea sicca - 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 - Apply to affected areas twice daily for eight to ten days.
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