OVACE Plus description, usages, side effects, indications, overdosage, supplying and lots more!

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OVACE Plus

Mission Pharmacal Company

OVACE® Plus Wash Cleansing Gel (sodium sulfacetamide 10%)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx Only



DESCRIPTION:
®

89232

OVACE Plus

CLINICAL PHARMACOLOGY:

®

INDICATIONS AND USAGE:

®

CONTRAINDICATIONS:

®

WARNINGS:

KEEP OUT OF THE REACH OF CHILDREN.

PRECAUTIONS:

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
General:
®

Information for Patients:®®

Drug Interactions:®

Pharmacology:®

Carcinogenesis, Mutagenesis and Impairment of Fertility:®

Pregnancy:®®®

Nursing Mothers:®

Pediatric Use:

ADVERSE REACTIONS:

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE:

50

Manifestations:

DOSAGE AND ADMINISTRATION:

Seborrheic dermatitis including seborrhea sicca - ®®

Secondary cutaneous bacterial infections -

HOW SUPPLIED:

®












OVACE Plus

OVACE Plus

SULFACETAMIDE SODIUM LIQUID

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0178-0490
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM SULFACETAMIDE 100 mg

Inactive Ingredients

Ingredient Name Strength
CETOSTEARYL ALCOHOL
PEG-3 DISTEAROYLAMIDOETHYLMONIUM METHOSULFATE
POLYSORBATE 60
COCAMIDOPROPYL BETAINE
EDETATE DISODIUM
GLYCERYL STEARATE SE
METHYLPARABEN
PEG-150 PENTAERYTHRITYL TETRASTEARATE
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES
water
SODIUM LAURETH SULFATE
SODIUM THIOSULFATE
XANTHAN GUM

Product Characteristics

Color
white

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0178-0490-12 355 in 1 BOTTLE, PLASTIC
2 5 in 1 PACKET
3 NDC:0178-0490-05 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-09-15


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