Dapsone 75 mg/g Gel
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Sulfone class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Dapsone topical is used to treat acne in children, teenagers, and adults. Dapsone is in a class of medications called sulfone antibiotics. It works by slowing or stopping the growth of bacteria and to decrease inflammation.
Read the full MedlinePlus article ↗- It depends on the form. The dapsone tablet is used to treat leprosy and a blistering, itchy skin condition called dermatitis herpetiformis. The topical gel — including Aczone Gel —...
- Gently wash your face and pat it dry first. Then squeeze out about a pea-sized amount of Aczone Gel, 7.5% and apply a thin layer across your whole face once a day. You can also app...
- With the gel, the most common ones are mild — some dryness, oiliness, peeling, or redness where you apply it. One thing to know: if you also use a benzoyl peroxide product, applyin...
- What side effects should I watch out for?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dapsone — tap one for details:
Dapsone may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dapsone 75 mg/g 00378-4830-60 | Mylan | 1 bottle | $0.729 | AB | Availability likely | — |
| dapsone 75 mg/g 13668-0605-05 | Torrent | 1 bottle | $0.729 | AB | Availability likely | — |
| Dapsone 75 mg/g 16714-0975-01 | NORTHSTAR | 1 bottle | $0.729 | AB | Availability likely | — |
| Dapsone 75 mg/g 68308-0342-60 | Mayne | 1 bottle | $0.729 | AB | Availability likely | — |
| Dapsone 75 mg/g 69238-1627-06 | Amneal | 1 bottle | $0.729 | AB | Availability likely | — |
| Aczone 75 mg/g 16110-0526-30 | Almirall, | 1 bottle | — | AB | Discontinued | — |
| Dapsone 75 mg/g 46708-0663-30 | Alembic | 1 bottle | — | AB | FDA listed | — |
| Dapsone 75 mg/g 51672-1388-02 | Sun | 1 bottle | — | AB | FDA listed | — |
| Dapsone 75 mg/g 52817-0832-60 | Trupharma, | 1 tube | — | AB | FDA listed | — |
| Dapsone 75 mg/g 62332-0663-30 | Alembic | 1 bottle | — | AB | FDA listed | — |
| Dapsone 75 mg/g 70771-1538-02 | Zydus | 1 bottle | — | AB | FDA listed | — |
| Dapsone 75 mg/gthis 72578-0094-01 | Viona | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 72578-0094-01 You're viewing this | 1 BOTTLE, PUMP in 1 CARTON (72578-094-01) / 30 g in 1 BOTTLE, PUMP | — | — | 2024-05-10 | Active |
| 72578-0094-02 | 1 BOTTLE, PUMP in 1 CARTON (72578-094-02) / 60 g in 1 BOTTLE, PUMP | $0.7287 / g | $43.72 | 2024-05-10 | Active |
| 72578-0094-03 | 1 BOTTLE, PUMP in 1 CARTON (72578-094-03) / 90 g in 1 BOTTLE, PUMP | $0.7979 / g | $71.81 | 2024-05-10 | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 72578-0094-01?
What NDC number is used to bill for this package of Dapsone 75 mg/g Gel?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Dapsone gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic, or intravaginal use. After the skin is gently washed and patted dry, apply approximately a pea-sized amount of dapsone gel, 7.5%, in a thin layer to the entire face once daily.
In addition, a thin layer may be applied to other affected areas once daily. Rub in dapsone gel, 7.5%, gently and completely. If there is no improvement after 12 weeks, treatment with dapsone gel, 7.5% should be reassessed.
Apply once daily ( 2 ). Apply approximately a pea-sized amount of dapsone gel, 7.5%, in a thin layer to the entire face. A thin layer can also be applied to other affected areas ( 2 ).
If there is no improvement after 12 weeks, treatment with dapsone gel, 7.5% should be reassessed ( 2 ). For topical use only. Not for oral, ophthalmic, or intravaginal use ( 2 ).
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Gel, 7.5%. Each gram of dapsone gel, 7.5% contains 75 mg of dapsone in an white, off white to yellow gel with suspended particles. Gel, 7.5% ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue dapsone gel if signs of methemoglobinemia occur ( 5.1 ). Hemolysis: Some patients with Glucose-6-phosphate Dehydrogenase (G6PD) deficiency using topical dapsone developed laboratory changes suggestive of hemolysis ( 5.1 ) ( 8.6 ).
5.1Hematological Effects Methemoglobinemia Cases of methemoglobinemia, with resultant hospitalization, have been reported postmarketing in association with twice daily dapsone gel, 5%, treatment. Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to drug-induced methemoglobinemia. Avoid use of dapsone gel, 7.5% in those patients with congenital or idiopathic methemoglobinemia.
Signs and symptoms of methemoglobinemia may be delayed some hours after exposure. Initial signs and symptoms of methemoglobinemia are characterized by a slate grey cyanosis seen in e.g., buccal mucous membranes, lips, and nail beds. Advise patients to discontinue dapsone gel, 7.5% and seek immediate medical attention in the event of cyanosis.
Dapsone can cause elevated methemoglobin levels particularly in conjunction with methemoglobin-inducing agents [see Drug Interactions ( 7.4 )] . He molysis Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6 -phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs.
G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry. In clinical trials, there was no evidence of clinically relevant hemolysis or hemolytic anemia in subjects treated with topical dapsone. Some subjects with G6PD deficiency using dapsone gel, 5%, twice daily developed laboratory changes suggestive of hemolysis [see Use in Specific Populations ( 8.6 )].
Discontinue dapsone gel, 7.5%, if signs and symptoms suggestive of hemolytic anemia occur. Avoid use of dapsone gel, 7.5% in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of dapsone gel, 7.5%, with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency [see Drug Interactions ( 7.1 )] .
5.2Peripheral Neuropathy Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical dapsone treatment.
5.3Skin Reactions Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types of skin reactions were not observed in clinical trials with topical dapsone treatment.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common (incidence ≥ 0.9%) adverse reactions are application site dryness and pruritus ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 2,161 subjects were treated with dapsone gel, 7.5%, for 12 weeks in 2 controlled clinical trials. The population ranged in age from 12 years to 63 years, was 56% female, and 58% Caucasian.
Adverse drug reactions that were reported in at least 0.9% of subjects treated with dapsone gel, 7.5% appear in Table 1 below. Table 1 Adverse Reactions Occurring in at Least 0.9% of Subjects with Acne Vulgaris in 12-week Controlled Clinical Trials Dapsone Gel, 7.5% (N =2,161) Vehicle (N =2,175) Application Site Dryness 24 (1.1%) 21 (1%) Application Site Pruritus 20 (0.9%) 11 (0.5%)
6.2Experience with Oral Use of Dapsone Although not observed in the clinical trials with topical dapsone, serious adverse reactions have been reported with oral use of dapsone, including agranulocytosis, hemolytic anemia, peripheral neuropathy (motor loss and muscle weakness), and skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria).
6.3Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of topical dapsone: methemoglobinemia, rash (including erythematous rash, application site rash) and swelling of face (including lip swelling, eye swelling).
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No formal drug-drug interaction studies were conducted with dapsone gel, 7.5%. Trimethoprim/sulfamethoxazole (TMP/SMX) increases the systemic level of dapsone and its metabolites ( 7.1 ). Topical benzoyl peroxide used at the same time as dapsone gel, 7.5% may result in temporary local yellow or orange skin discoloration ( 7.2 ).
7.1Trimethoprim-Sulfamethoxazole A drug-drug interaction study evaluated the effect of the use of dapsone gel, 5% in combination with double strength (160 mg/800 mg) trimethoprim-sulfamethoxazole (TMP/SMX). During co-administration, systemic levels of TMP and SMX were essentially unchanged, however, levels of dapsone and its metabolites increased in the presence of TMP/SMX. The systemic exposure from dapsone gel, 7.5% is expected to be about 1% of that from the 100 mg oral dose, even when co-administered with TMP/SMX.
7.2Topical Benzoyl Peroxide Topical application of dapsone gel followed by benzoyl peroxide in patients with acne vulgaris may result in a temporary local yellow or orange discoloration of the skin and facial hair.
7.3Drug Interactions with Oral Dapsone Certain concomitant medications (such as rifampin, anticonvulsants, St. John's wort) may increase the formation of dapsone hydroxylamine, a metabolite of dapsone associated with hemolysis. With oral dapsone treatment, folic acid antagonists such as pyrimethamine have been noted to possibly increase the likelihood of hematologic reactions.
7.4Concomitant Use with Drugs that Induce Methemoglobinemia Concomitant use of dapsone gel, 7.5% with drugs that induce methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para‐aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia [see Warnings and Precautions ( 5.1 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on dapsone gel, 7.5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. The systemic absorption of dapsone in humans following topical application is low relative to oral dapsone administration [see Clinical Pharmacology ( 12.3 )] . In animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 400 times the systemic exposure at the maximum recommended human dose (MRHD) of dapsone gel, 7.5%, resulted in embryocidal effects.
When orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 500 times the exposure at the MRHD, dapsone resulted in increased stillbirths and decreased pup weight [see Data] . The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Da ta A nimal Data Dapsone has been shown to have an embryocidal effect in rats and rabbits when administered orally daily to females during organogenesis at dosages of 75 mg/kg/day and 150 mg/kg/day, respectively. These dosages resulted in systemic exposures that represented approximately 1,407 times [rats] and 425 times [rabbits] the systemic exposure observed in human females as a result of use of the MRHD of dapsone gel, 7.5%, based on AUC comparisons. These effects were probably secondary to maternal toxicity.
Dapsone was assessed for effects on perinatal/postnatal pup development and postnatal maternal behavior and function in a study in which dapsone was orally administered to female rats daily beginning on the seventh day of gestation and continuing until the twenty-seventh day postpartum. Maternal toxicity (decreased body weight and food consumption) and developmental effects (increase in stillborn pups and decreased pup weight) were seen at a dapsone dose of 30 mg/kg/day (approximately 563 times the systemic exposure that is associated with the MRHD of dapsone gel, 7.5%, based on AUC comparisons).
No effects were observed on the viability, physical development, behavior, learning ability, or reproductive function of surviving pups.
8.2Lactation Risk Summary There is no information regarding the presence of topical dapsone in breastmilk, the effects on the breastfed infant or the effects on milk production. Orally administered dapsone appears in human milk and could result in hemolytic anemia and hyperbilirubinemia especially in infants with G6PD deficiency. Systemic absorption of dapsone following topical application is low relative to oral dapsone administration.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for dapsone gel, 7.5% and any potential adverse effects on the breastfed child from dapsone gel, 7.5% or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of dapsone gel, 7.5% for the topical treatment of acne vulgaris have been established in patients 9 years of age and older. Use of dapsone gel, 7.5% in patients 9 years to 11 years of age for this indication is supported by evidence from adequate and well-controlled clinical trials in 1,066 subjects 12 years of age and older and with additional pharmacokinetic and safety data in pediatric subjects 9 years to 11 years of age from an open label study of 100 subjects with acne [see Adverse Reactions ( 6.1 ), and Clinical Pharmacology ( 12.3 )] .
The safety profile for dapsone gel, 7.5% in clinical trials was similar to the vehicle control group. Safety and effectiveness of dapsone gel, 7.5%, have not been established in pediatric patients below the age of 9 years.
8.5 Geriatric Use Clinical…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on dapsone gel, 7.5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. The systemic absorption of dapsone in humans following topical application is low relative to oral dapsone administration [see Clinical Pharmacology ( 12.3 )] . In animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 400 times the systemic exposure at the maximum recommended human dose (MRHD) of dapsone gel, 7.5%, resulted in embryocidal effects.
When orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 500 times the exposure at the MRHD, dapsone resulted in increased stillbirths and decreased pup weight [see Data] . The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Da ta A nimal Data Dapsone has been shown to have an embryocidal effect in rats and rabbits when administered orally daily to females during organogenesis at dosages of 75 mg/kg/day and 150 mg/kg/day, respectively. These dosages resulted in systemic exposures that represented approximately 1,407 times [rats] and 425 times [rabbits] the systemic exposure observed in human females as a result of use of the MRHD of dapsone gel, 7.5%, based on AUC comparisons. These effects were probably secondary to maternal toxicity.
Dapsone was assessed for effects on perinatal/postnatal pup development and postnatal maternal behavior and function in a study in which dapsone was orally administered to female rats daily beginning on the seventh day of gestation and continuing until the twenty-seventh day postpartum. Maternal toxicity (decreased body weight and food consumption) and developmental effects (increase in stillborn pups and decreased pup weight) were seen at a dapsone dose of 30 mg/kg/day (approximately 563 times the systemic exposure that is associated with the MRHD of dapsone gel, 7.5%, based on AUC comparisons).
No effects were observed on the viability, physical development, behavior, learning ability, or reproductive function of surviving pups.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of dapsone gel, 7.5% for the topical treatment of acne vulgaris have been established in patients 9 years of age and older. Use of dapsone gel, 7.5% in patients 9 years to 11 years of age for this indication is supported by evidence from adequate and well-controlled clinical trials in 1,066 subjects 12 years of age and older and with additional pharmacokinetic and safety data in pediatric subjects 9 years to 11 years of age from an open label study of 100 subjects with acne [see Adverse Reactions ( 6.1 ), and Clinical Pharmacology ( 12.3 )] .
The safety profile for dapsone gel, 7.5% in clinical trials was similar to the vehicle control group. Safety and effectiveness of dapsone gel, 7.5%, have not been established in pediatric patients below the age of 9 years.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical trials of dapsone gel, 7.5% did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of dapsone gel in treating acne vulgaris is not known.
12.3Pharmacokinetics In a pharmacokinetic study, male and female subjects 16 years of age or older with acne vulgaris (N=19) applied 2 grams of dapsone gel, 7.5% to the face, upper chest, upper back and shoulders once daily for 28 days. Steady state for dapsone was reached within 7 days of dosing. On Day 28, the mean dapsone maximum plasma concentration (C max ) and area under the concentration-time curve from 0 to 24 hours post dose (AUC 0-24h ) were 13.0 ± 6.8 ng/mL and 282 ± 146 ng∙h/mL, respectively.
The systemic exposure from dapsone gel, 7.5% is expected to be about 1% of that from a 100 mg oral dose. Long-term safety studies were not conducted with dapsone gel, 7.5%, however, in a long-term clinical study of dapsone gel, 5% treatment (twice daily), periodic blood samples were collected up to 12 months to determine systemic exposure of dapsone and its metabolites in approximately 500 subjects. Based on the measurable dapsone concentrations from 408 subjects (M=192, F=216), obtained at Month 3, neither gender nor race appeared to affect the pharmacokinetics of dapsone.
Similarly, dapsone exposures were approximately the same between the age groups of 12 years to 15 years (N=155) and those greater than or equal to 16 years (N=253). There was no evidence of increasing systemic exposure to dapsone over the study year in these subjects. In an open label safety and pharmacokinetic study in pediatric subjects 9 years to 11 years of age with acne vulgaris, a subset of subjects (N = 16) received once daily topical application of approximately 2 grams of dapsone gel, 7.5%, to the entire face, shoulders, upper chest and upper back for 8 days.
On Day 8, the systemic concentrations were at or near steady state and the mean ± SD systemic concentration of dapsone at 10 hours post dose was 20 ± 12.5 ng/mL.
12.4Microbiology I n Vivo Ac tivity : No microbiology or immunology studies were conducted during dapsone gel, 7.5% clinical studies. Dr u g Resistance : No dapsone resistance studies were conducted during dapsone gel clinical studies therefore there are no data available as to whether dapsone treatment may have resulted in decreased susceptibility of P ropionibacterium acnes , an organism associated with acne, or to other antimicrobials that may be used to treat acne. Therapeutic resistance to dapsone has been reported for Mycobacterium leprae , when patients have been treated with oral dapsone.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of dapsone gel in treating acne vulgaris is not known.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Dapsone gel, 7.5% is a white, off white to yellow gel with suspended particles. It is supplied in an airless pump containing a polypropylene bottle with a high density polyethylene piston. Dapsone Gel, 7.5%, is supplied in the following sizes: NDC 72578-094-01 30 gram pump NDC 72578-094-02 60 gram pump NDC 72578-094-03 90 gram pump Storage : Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature].
Protect from freezing.
📋 Description ▾
11 DESCRIPTION Dapsone gel, 7.5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 7.5% is an white, off white to yellow gel with suspended particles. Chemically, dapsone has an molecular formula of C 12 H 12 N 2 O 2 S.
It is a white or creamy white, crystalline powder that has a molecular weight of 248.30. Dapsone's chemical name is 4-[(4-aminobenzene) sulfonyl] aniline and its structural formula is: Each gram of dapsone gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water. Image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). He matological Effects Inform patients that methemoglobinemia can occur with topical dapsone treatment. Advise patients to seek immediate medical attention if they develop cyanosis [see Warnings and Precautions ( 5.1 )].
Inform patients who have G6PD deficiency that hemolytic anemia may occur with topical dapsone treatment. Advise patients to seek medical attention if they develop signs and symptoms suggestive of hemolytic anemia [see Warnings and Precautions ( 5.1 )]. I mportant Administration Instructions Advise patients to apply dapsone gel, 7.5%, once daily to the entire face [see Dosage and Administration ( 2 )].
Dapsone gel, 7.5% is for topical use only. Do not apply dapsone gel, 7.5% to eyes, mouth, or mucous membranes.