Sulfacetamide 10%/sulfur 5% Lotion
It is used to treat pimples (acne).It is used to treat rosacea.It is used to control seborrheic dermatitis.
Drug Class
Anti-acne agent; Anti-rosacea agent
Pharmacologic Class
Topical sulfonamide antibiotic; Keratolytic agent
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This lotion contains two active ingredients: sulfur and sulfacetamide. Sulfur helps to dry out and peel away dead skin cells, which can unclog pores. Sulfacetamide is an antibiotic that helps stop the growth of bacteria on the skin. Together, they are used to treat skin conditions like acne, rosacea, and seborrheic dermatitis by reducing inflammation, redness, and breakouts.
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. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause irritation or burning. If accidental contact occurs, rinse the area with water.
Before applying the medication, wash your hands thoroughly. Clean the affected area and dry it completely to ensure the medication adheres properly. Apply a thin layer of the medication to the affected area and gently rub it in.
Continue using the medication as directed by your doctor, even if your symptoms improve. Unless instructed otherwise by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storage and Disposal
To maintain the medication's effectiveness, store it at room temperature, away from freezing temperatures. Keep the container tightly closed and store it in a dry place, avoiding bathrooms.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, 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 one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause irritation or burning. If accidental contact occurs, rinse the area with water.
Before applying the medication, wash your hands thoroughly. Clean the affected area and dry it completely to ensure the medication adheres properly. Apply a thin layer of the medication to the affected area and gently rub it in.
Continue using the medication as directed by your doctor, even if your symptoms improve. Unless instructed otherwise by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storage and Disposal
To maintain the medication's effectiveness, store it at room temperature, away from freezing temperatures. Keep the container tightly closed and store it in a dry place, avoiding bathrooms.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, 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 one.
Lifestyle & Tips
- Cleanse skin gently before application.
- Apply a thin layer to affected areas only.
- Avoid contact with eyes, mouth, and mucous membranes.
- Wash hands thoroughly after application.
- Use sunscreen and protective clothing, as sulfur can increase sun sensitivity.
- Avoid harsh soaps, abrasive cleansers, or other irritating topical products unless directed by your doctor.
- Be patient; it may take several weeks to see improvement.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas 1 to 3 times daily, or as directed by physician.
Condition-Specific Dosing:
acne_vulgaris:
Apply to affected areas after cleansing, usually once or twice daily.
rosacea:
Apply to affected areas after cleansing, usually once or twice daily.
seborrheic_dermatitis:
Apply to affected areas after cleansing, usually once or twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy generally not established for children under 12 years)
Adolescent:
Apply a thin layer to affected areas 1 to 3 times daily, or as directed by physician (typically for ages 12 and older).
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 due to 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: A sulfonamide antibiotic that competitively inhibits bacterial dihydropteroate synthase, an enzyme essential for the synthesis of folic acid. This action prevents bacterial growth. It also has anti-inflammatory properties, which may contribute to its efficacy in conditions like rosacea. Sulfur: Acts as a keratolytic agent, promoting the shedding of dead skin cells and unclogging pores. It also possesses mild antibacterial and antifungal properties, and may reduce sebum production.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <4% for sulfacetamide, negligible for sulfur) from topical application.
Tmax:
Not applicable for systemic effects due to minimal absorption.
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not applicable for systemic effects due to minimal absorption.
ProteinBinding:
Not applicable for systemic effects due to minimal absorption.
CnssPenetration:
No (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable for systemic effects due to minimal absorption.
Clearance:
Not applicable for systemic effects due to minimal absorption.
ExcretionRoute:
Not applicable for systemic effects due to minimal absorption.
Unchanged:
Not applicable for systemic effects due to minimal absorption.
Pharmacodynamics
OnsetOfAction:
Weeks for noticeable improvement (typically 2-4 weeks).
PeakEffect:
Several weeks to months of consistent use.
DurationOfAction:
Maintained with continued use; effects diminish upon discontinuation.
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 signs or symptoms, contact your doctor or seek medical attention immediately:
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
Skin irritation
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
+ Cough that is new or worsening
+ 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, resulting in one death. Seek medical attention immediately if you experience:
+ A 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
Most people taking this medication will not experience side effects or will only have mild side effects. However, if you notice any of the following, contact your doctor or seek medical attention:
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 signs or symptoms, contact your doctor or seek medical attention immediately:
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
Skin irritation
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
+ Cough that is new or worsening
+ 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, resulting in one death. Seek medical attention immediately if you experience:
+ A 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
Most people taking this medication will not experience side effects or will only have mild side effects. However, if you notice any of the following, contact your doctor or seek medical attention:
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 burning, stinging, or itching that does not subside.
- Excessive redness, swelling, or peeling of the skin.
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat).
- Unusual skin discoloration (e.g., yellowing of skin or hair, especially with concurrent dapsone use).
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, including any symptoms.
A known sulfa allergy, as this may affect your ability to take this medication.
The use of any medications containing silver, as this may interact with this drug.
The presence of kidney disease, as this may impact the safety and effectiveness of this medication.
This list is not exhaustive, and it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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, including any symptoms.
A known sulfa allergy, as this may affect your ability to take this medication.
The use of any medications containing silver, as this may interact with this drug.
The presence of kidney disease, as this may impact the safety and effectiveness of this medication.
This list is not exhaustive, and it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When applying this drug, avoid using it on cuts, scrapes, or damaged skin, as this can exacerbate skin irritation. Additionally, using other skin products concurrently with this medication may increase the risk of irritation. Therefore, it is crucial to consult with your doctor before using any other drugs or products on your skin, including soaps.
Adhere to your doctor's instructions regarding the duration of use, as using this drug for an extended period beyond the recommended timeframe can worsen your skin condition.
To prevent staining, take precautions to protect your clothing and fabrics, as this drug may cause discoloration.
In the event of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
When applying this drug, avoid using it on cuts, scrapes, or damaged skin, as this can exacerbate skin irritation. Additionally, using other skin products concurrently with this medication may increase the risk of irritation. Therefore, it is crucial to consult with your doctor before using any other drugs or products on your skin, including soaps.
Adhere to your doctor's instructions regarding the duration of use, as using this drug for an extended period beyond the recommended timeframe can worsen your skin condition.
To prevent staining, take precautions to protect your clothing and fabrics, as this drug may cause discoloration.
In the event of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive topical application may lead to severe local irritation (redness, peeling, burning).
- If ingested (accidental): Nausea, vomiting, diarrhea, abdominal pain, headache, dizziness. Large ingestions of sulfonamides can lead to crystalluria, kidney damage, or blood dyscrasias.
What to Do:
For topical overdose, wash off excess medication with water. For accidental ingestion, seek immediate medical attention or call a poison control center (1-800-222-1222). Management is supportive.
Drug Interactions
Contraindicated Interactions
- Hypersensitivity to sulfonamides, sulfur, or any component of the formulation.
- Kidney disease (due to theoretical risk of systemic absorption in patients with impaired renal function, though minimal for topical use).
- Infants under 2 months of age (due to risk of kernicterus with systemic sulfonamides).
Moderate Interactions
- Topical dapsone (potential for skin discoloration if applied concurrently).
Minor Interactions
- Other topical acne medications (e.g., retinoids, benzoyl peroxide): May increase skin irritation, dryness, or peeling if used concurrently or without proper spacing.
Monitoring
Baseline Monitoring
Skin assessment (type, severity of condition, presence of irritation)
Rationale: To establish baseline for efficacy and adverse effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in lesions, redness)
Frequency: Monthly or as clinically indicated
Target: Improvement in skin condition
Action Threshold: Lack of improvement after 6-8 weeks, or worsening of condition, warrants re-evaluation.
Local skin irritation (redness, dryness, peeling, itching, burning)
Frequency: Regularly, especially during initial weeks of therapy
Target: Minimal to no irritation
Action Threshold: Moderate to severe irritation warrants reduction in frequency, temporary discontinuation, or change in therapy.
Symptom Monitoring
- Skin redness
- Dryness
- Peeling or flaking
- Itching
- Burning or stinging sensation
- Swelling
- Allergic reaction (rash, hives, difficulty breathing - rare but serious)
Special Patient Groups
Pregnancy
Use with caution during pregnancy. While systemic absorption is minimal, sulfacetamide is a sulfonamide, and systemic sulfonamides are Category C (risk of kernicterus if used near term). Discuss potential benefits vs. risks with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk due to minimal systemic absorption.
Second Trimester:
Generally considered low risk due to minimal systemic absorption.
Third Trimester:
Avoid use near term (last trimester) due to theoretical risk of kernicterus in the neonate if significant systemic absorption were to occur, though highly unlikely with topical use.
Lactation
Use with caution. Sulfonamides are excreted in breast milk. While systemic absorption from topical application is minimal, monitor the infant for potential adverse effects (e.g., diarrhea, rash). Avoid applying to areas where the infant may ingest the medication.
Infant Risk:
L3 (Moderately Safe) - Potential for infant exposure via breast milk, but low risk due to minimal maternal systemic absorption. Observe infant for jaundice, rash, or diarrhea.
Pediatric Use
Safety and efficacy generally not established for children under 12 years of age. Use in adolescents (12 years and older) is common and generally well-tolerated. Avoid use in infants under 2 months due to theoretical risk of kernicterus.
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
- This combination is particularly useful for patients with both acne and rosacea, as it addresses both bacterial components and inflammation.
- Patients should be advised that the lotion may have a characteristic sulfur odor, which can be more noticeable when first applied.
- Some formulations may cause temporary yellowing of light-colored fabrics or hair.
- Consistent, long-term use is often necessary for optimal results and maintenance of improvement.
- If excessive dryness or irritation occurs, reduce frequency of application (e.g., every other day) or use a gentle moisturizer.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline for severe cases)
- Oral isotretinoin (for severe, recalcitrant acne)
- Dermatological procedures (e.g., chemical peels, laser therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $50 - $300+ per 60g or 120g tube/bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization for brand, generics may be preferred)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 details about the medication taken, the amount, and the time it occurred.