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Name:Ovaceplus
Manufacturer:Tiber Laboratories, Llc.
Category:Prescription Marketed Drugs


Ovace® Plus Wash (Sodium Sulfacetamide 10%)

OVACE PLUS - sulfacetamide sodium lotion/shampoo 
Tiber Laboratories, LLC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Ovace® Plus Wash (Sodium Sulfacetamide 10%)

DESCRIPTION:

Each gram of Ovace® Plus Wash contains 100 mg of sodium sulfacetamide USP incorporated into a specially formulated oil and water emulsion (OIW)™ vehicle consisting of Cocamidopropyl Betaine, Sodium Thiosulfate, PEG-60 Almond Triglycerides, PEG-150 Pentaerythrityl Tetrastearate and Aqua and PEG-6 Caprylic/Capric Glycerides, Cetearyl Alcohol and PEG-3 Distearoylamidoethylmonium Methosulfate and Polysorbate 60, Disodium EDTA, Glyceryl Monostearate SE, Polysorbate 60, Purified Water, Methyl Paraben and Sodium Laureth Sulfate.

Sodium sulfacetamide is C8H9N2NaO3S·H2O with molecular weight of 254.24. Chemically, it is Acetamide N-[4-aminophenyl)sulfonyl]-, monosodium salt, monohydrate, with the following structural formula:

structure

Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.

This OIW™ formulation has been shown to provide gradual and prolonged release of the active ingredient into the skin.

CLINICAL PHARMACOLOGY:

Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There are no clinical data available on the degree and rate of systemic absorption of Ovace® Plus Wash when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported.

The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.

INDICATIONS AND USAGE:

Ovace® Plus Wash 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.

CONTRAINDICATIONS:

Ovace® Plus Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.

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.

PRECAUTIONS:

For external use only.

General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If Ovace® Plus Wash produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed.

Information For Patients: Patients should discontinue Ovace® Plus Wash if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Ovace® Plus Wash also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop.

Drug Interactions: Ovace® Plus Wash is incompatible with silver preparations.

Pharmacology:Ovace® Plus Wash has a bacteriostatic effect against Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on Ovace® Plus Wash to date. Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide has been reported. The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown.

Pregnancy Category C: Animal reproduction studies have not been conducted with Ovace® Plus Wash. It also is not known whether Ovace® Plus Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ovace® Plus Wash should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Nursing Mothers:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ovace® Plus Wash is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children under the age of 12 years have not been established.

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.)

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

OVERDOSAGE:

The oral LD50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately.

Manifestations:
Overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria, and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center.

DOSAGE AND ADMINISTRATION:

Sehorrheic dermatitis including seborrhea siccaOvace® Plus Wash: Wash affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. lf skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. Regular shampooing following Ovace® Plus Wash is not necessary, but the hair should be shampooed at least once a week. 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 Ovace® Plus Wash should be reinitiated as at the beginning of treatment.

Secondary Cutaneous Bacterial Infections—Wet skin and liberally apply to areas to be cleansed, massage gently into skin working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less often.

HOW SUPPLIED:

Ovace® Plus Wash is available in a 16 fl. oz, NDC 23589-019-16 bottle and a 5 gram sample packette, NDC 23589-019-15.

STORAGE:

Store at controlled room temperature 15°C–30°C (59°F–86°F). Do not freeze.

Note: Store upright. Protect from freezing and excessive heat. The wash may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Occasionally, a slight yellowish discoloration may occur when an excessive amount of the wash is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches.

logo

Manufactured for:
TIBER LABORATORIES
Suwanee, GA 30024

PATENT PENDING

PACKAGING:

NDC 23589-019-16
Rx Only
Ovace® Plus Wash
(Sodium Sulfacetamide 10%)
16 FL OZ

Ingredients: contains 100 mg of Sodium Sulfacetamide USP incorporated into a specially formulated oil and water emulsion (OIW)™ vehicle consisting of Cocamidopropyl Betaine, Sodium Thiosulfate, PEG-60 Almond Triglycerides, PEG-150 Pentaerythrityl Tetrastearate and Aqua and PEG-6 Caprylic/Capric Glycerides, Cetearyl Alcohol and PEG-3 Distearoylamidoethylmonium Methosulfate and Polysorbate 60, Disodium EDTA, Glyceryl Monostearate SE, Polysorbate 60, Purified Water, Methyl Paraben and Sodium Laureth Sulfate.

Directions:
Wash affected areas twice daily (morning and evening) or as directed by your physician. Rinse thoroughly and pat dry. See package insert for complete product information.

Storage: Store upright at controlled room temperature. 15°–30°C (59°–86°F). Do not freeze.

WARNING: FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.


Manufactured for:
TIBER LABORATORIES
Suwanee, GA 30024
Patent Pending

Sample label:

label


OVACE  PLUS
sulfacetamide sodium lotion/shampoo
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23589-019
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
COCAMIDOPROPYL BETAINE  
SODIUM THIOSULFATE  
POLYETHYLENE GLYCOL 3000  
POLYETHYLENE GLYCOL 300  
CETOSTEARYL ALCOHOL  
POLYSORBATE 60  
EDETATE DISODIUM  
GLYCERYL MONOSTEARATE  
WATER  
METHYLPARABEN  
SODIUM LAURETH SULFATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:23589-019-16 473 mL in 1 BOTTLE None
2 NDC:23589-019-15 15 mL in 1 PACKET None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2009 07/31/2011

Labeler - Tiber Laboratories, LLC. (008913939)

Revised: 03/2011 Tiber Laboratories, LLC.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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