INDICATIONS: The OVACE® (sodium sulfacetamide) product family (OVACE® Plus Cream, OVACE® Plus Lotion, OVACE® Plus Shampoo, OVACE® Plus Wash, OVACE® Plus Wash Cleansing Gel) are prescription medicines intended for use on the skin and/or scalp (topical) for the treatment of seborrheic dermatitis and seborrhea sicca (dandruff). OVACE Plus Cream, OVACE Plus Lotion, OVACE Plus Wash, and OVACE Plus Wash Cleansing Gel are also used to treat certain bacterial infections of the skin. OVACE products contain sodium sulfacetamide, a sulfonamide antibiotic, which prevents bacteria from growing.
Important Safety Information
OVACE products are not for everyone. You should not use OVACE products if you:
are allergic to any ingredient in OVACE products. Ask your doctor if you are not sure
have had a severe allergic reaction (e.g., severe rash, hives, difficulty breathing, swelling) to sulfonamide medicines or sulfur.
have kidney disease.
KEEP ALL OVACE PRODUCTS OUT OF THE REACH OF CHILDREN.
Before you use OVACE products, tell your doctor about all of your medical conditions, including if you:
are pregnant or planning to become pregnant. It is not known whether OVACE products can cause harm to the fetus.
are breastfeeding or plan to breastfeed. It is not known whether the ingredients in OVACE products can pass into breast milk.
have allergies to medicines, foods, or other substances.
OVACE PRODUCTS ARE FOR EXTERNAL USE ONLY. AVOID CONTACT WITH THE EYES.
OVACE products should be used as directed by your doctor. Do not use them for other conditions. OVACE products should not be used in children younger than 12 years old; safety and effectiveness in these children have not been determined.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. You should tell your doctor if you are using silver-containing medicines, such as silver sulfadiazine.
OVACE products may cause serious side effects in some people, including:
severe allergic reactions. You should discontinue any OVACE product if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Seek medical attention right away if you develop signs or symptoms of a severe allergic reaction (rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue).
systemic lupus erythematosus. In one of these cases there was a fatal outcome. Discontinue the OVACE product immediately and contact your doctor right away if you experience arthritis (pain, stiffness or swelling in your joints), fever, or sores in your mouth develop.
Possible side effects of OVACE products include mild skin irritation or dryness. These are not all of the possible side effects of OVACE products. Tell your doctor if you have any side effect that bothers you or does not go away.
You may report negative side effects to Mission Pharmacal Company at 1-800-298-1087, or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.