Ovace Plus 10% Wash Gel 355ml
It is used to treat bacterial infections.It is used to control seborrheic dermatitis.It is used to treat dandruff.
Drug Class
Anti-acne agent; Antibacterial
Pharmacologic Class
Sulfonamide antibiotic
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ovace Plus 10% Wash Gel is a topical medication containing sulfacetamide, an antibiotic that helps treat acne by reducing the bacteria on your skin and decreasing inflammation. It's used as a wash to cleanse and treat affected areas.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Do not take this medication by mouth. It is for skin use only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep the lid tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Do not take this medication by mouth. It is for skin use only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep the lid tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Cleanse skin thoroughly before applying.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use on broken or irritated skin.
- Use a non-comedogenic moisturizer if skin dryness occurs.
- Avoid excessive sun exposure and use sunscreen, as sulfacetamide may increase sun sensitivity.
- Do not use if you have a known allergy to sulfonamides or sulfa drugs.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas 1-2 times daily, or as directed by physician.
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to cleansed affected areas, gently massage into skin. Rinse thoroughly after application if it's a wash.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established for children under 12 years; use with caution and physician guidance.
Adolescent:
Apply to affected areas 1-2 times daily, similar to adult dosing, or as directed by physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations for topical use (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Sulfacetamide is a sulfonamide antibiotic that exerts its antibacterial effect by inhibiting the growth of susceptible bacteria. It interferes with bacterial para-aminobenzoic acid (PABA) utilization, an essential component in the synthesis of folic acid, which is necessary for bacterial growth. This leads to bacteriostatic action. In acne, it targets Propionibacterium acnes (now Cutibacterium acnes) and may also have anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically less than 4% from topical application)
Tmax:
Not applicable for systemic Tmax due to minimal absorption; local concentration achieved rapidly.
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Days to weeks for clinical improvement in acne.
PeakEffect:
Weeks to months for optimal therapeutic effect.
DurationOfAction:
Requires continued application for sustained effect.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Rare but severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
If you experience any of the following, call your doctor right away:
+ Rash
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
+ Fever, chills, or sore throat
+ New or worsening cough
+ Feeling very tired or weak
+ Any bruising or bleeding
+ Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
A health problem called lupus has been reported with drugs like this one. If you experience any of the following symptoms, contact your doctor right away:
+ Rash on your cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
* Skin irritation
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Rare but severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
If you experience any of the following, call your doctor right away:
+ Rash
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
+ Fever, chills, or sore throat
+ New or worsening cough
+ Feeling very tired or weak
+ Any bruising or bleeding
+ Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
A health problem called lupus has been reported with drugs like this one. If you experience any of the following symptoms, contact your doctor right away:
+ Rash on your cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
* Skin irritation
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation, redness, burning, or itching that worsens or does not subside.
- Rash, hives, or swelling (signs of allergic reaction).
- Yellowing of skin or eyes (jaundice), dark urine, or unusual tiredness (rare, but indicates potential systemic reaction).
- Sore throat, fever, or unusual bruising/bleeding (rare, but indicates potential blood dyscrasias).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A known sulfa allergy.
Current use of medications containing silver.
Presence of kidney disease.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A known sulfa allergy.
Current use of medications containing silver.
Presence of kidney disease.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To avoid staining, take precautions to protect your clothing and fabrics when using this drug, as it may cause discoloration.
Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.
Do not use this medication for an extended period beyond the recommended duration, as this may lead to a secondary infection. Additionally, excessive use of this drug can worsen your skin condition.
Note that different brands of this medication may be suitable for children of various ages. Therefore, it is crucial to consult with your doctor before administering this drug to a child.
When applying this medication to a large area of skin or near open wounds, exercise caution and discuss any concerns with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication with you, considering both your health and the baby's well-being.
To avoid staining, take precautions to protect your clothing and fabrics when using this drug, as it may cause discoloration.
Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.
Do not use this medication for an extended period beyond the recommended duration, as this may lead to a secondary infection. Additionally, excessive use of this drug can worsen your skin condition.
Note that different brands of this medication may be suitable for children of various ages. Therefore, it is crucial to consult with your doctor before administering this drug to a child.
When applying this medication to a large area of skin or near open wounds, exercise caution and discuss any concerns with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication with you, considering both your health and the baby's well-being.
Overdose Information
Overdose Symptoms:
- Unlikely with topical use due to minimal systemic absorption.
- Excessive local irritation, redness, or peeling if applied too frequently or in large amounts.
What to Do:
Discontinue use and wash off thoroughly. If severe irritation persists, consult a healthcare professional. For accidental ingestion, call 1-800-222-1222 (Poison Control).
Drug Interactions
Minor Interactions
- PABA-containing sunscreens (theoretical antagonism of sulfacetamide's action, though unlikely with topical use)
- Silver sulfadiazine (potential for cross-sensitivity)
Monitoring
Routine Monitoring
Skin irritation (redness, itching, burning, dryness)
Frequency: Daily, during initial treatment phase
Target: Minimal to no irritation
Action Threshold: Discontinue if severe irritation or allergic reaction occurs; consult physician.
Clinical improvement of acne lesions
Frequency: Monthly
Target: Reduction in number and severity of lesions
Action Threshold: Re-evaluate treatment if no improvement after 6-8 weeks.
Symptom Monitoring
- Local skin irritation (redness, itching, burning, dryness)
- Allergic reactions (rash, hives, swelling)
- Worsening of acne
- Unusual skin discoloration
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, sulfonamides can cross the placenta. Avoid use near term due to theoretical risk of kernicterus in neonates.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though low with topical use.
Second Trimester:
Generally considered safer than first or third, but still Category C.
Third Trimester:
Avoid use near term (last trimester) due to theoretical risk of kernicterus in the neonate, especially in premature infants or those with hyperbilirubinemia.
Lactation
L3 (Moderately Safe). Minimal systemic absorption suggests low risk to the nursing infant. However, sulfonamides are excreted in breast milk. Use with caution, especially if the infant is jaundiced, premature, or has G6PD deficiency. Avoid applying to areas where the infant may ingest the medication.
Infant Risk:
Low risk for healthy, full-term infants due to minimal maternal systemic absorption. Theoretical risk of kernicterus in infants with hyperbilirubinemia or G6PD deficiency.
Pediatric Use
Safety and efficacy not fully established for children under 12 years. Use in adolescents is generally similar to adults. Careful consideration for younger children due to potential for increased systemic absorption through immature skin or larger surface area to body weight ratio.
Geriatric Use
No specific dosage adjustments are typically required for geriatric patients. Use with caution in patients with very sensitive or fragile skin, as they may be more prone to irritation.
Clinical Information
Clinical Pearls
- Sulfacetamide topical preparations are often used for acne, rosacea, and seborrheic dermatitis due to their antibacterial and anti-inflammatory properties.
- Patients should be advised that improvement may take several weeks of consistent use.
- The wash formulation is designed for cleansing and treatment, often rinsed off after a short contact time.
- Patients with a history of allergy to sulfonamides (sulfa drugs) should not use this product.
- Some formulations may cause temporary yellowing of the skin or hair, especially if left on for prolonged periods or if the patient has light-colored hair.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Azelaic acid
- Oral antibiotics (for more severe acne)
- Isotretinoin (for severe, recalcitrant acne)
Cost & Coverage
Average Cost:
Varies widely ($30 - $200+) per 355ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require prior authorization for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.