Clindamycin Phosphate and Tretinoin 10 mg/g; .25 mg/g Gel
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Retinoid class.
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🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Topical clindamycin is used to treat acne. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria that cause acne and by decreasing swelling.
Read the full MedlinePlus article ↗- It targets acne from two directions at once. The clindamycin in it is an antibiotic that fights the bacteria linked to acne breakouts, while tretinoin helps unclog your pores by sp...
- What is this gel actually supposed to do for my acne?
- Apply it once a day at bedtime (or in the evening for Veltin). Squeeze out a pea-sized amount — that's really all you need — dot it onto your chin, cheeks, nose, and forehead, then...
- Yes, that's very common when you first start, especially with the tretinoin component. Redness, dryness, peeling, itching, and a mild burning or stinging feeling are all reported s...
Patient education
Supplement & herbal interactions
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🧪 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?
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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 | $3.398 | $203.85 / 60 g |
| Medicaid paysCMS SDUD · 12 mo | $5.47 | $328.38 / 60 g |
| Medicare drug plans payPart D · Q2 2026 | $6.94 | $416.42 / 60 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clindamycin Phosphate and Tretinoin 10 mg/g; .25 mg/gthis 73473-0306-60 | Solaris | 1 tube | $3.398 | AB2 | Availability likely | — |
| Clindamycin Phosphate and Tretinoin 12 mg/g; .25 mg/g 00472-1790-30 | Actavis | 1 tube | $4.328 | AB1 | Availability likely | +27% |
| Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% 10 mg/g; .25 mg/g 21922-0050-05 | Encube | 1 tube | $4.328 | AB2 | Availability likely | +27% |
| Clindamycin Phosphate 1.2% and Tretinoin 0.025% 12 mg/g; .25 mg/g 68682-0300-30 | Oceanside | 1 tube | $6.545 | AB1 | FDA listed | +93% |
| Ziana 12 mg/g; .25 mg/g 99207-0300-30 | Bausch | 1 tube | — | AB1 | 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 & spend
💊 Medicaid utilization by pack size
🔬 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 |
|---|---|---|---|---|---|
| 73473-0306-30 | 1 TUBE in 1 CARTON (73473-306-30) / 30 g in 1 TUBE | $4.33 / g | $129.85 | 2023-10-19 | Active |
| 73473-0306-60 You're viewing this | 1 TUBE in 1 CARTON (73473-306-60) / 60 g in 1 TUBE | $3.40 / g | $203.85 | 2023-10-19 | Active |
This pack has the lowest per-g cost of the 2 priced pack sizes ($3.40 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 74% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 73473-0306-60?
What NDC number is used to bill for this package of Clindamycin Phosphate and Tretinoin 10 mg/g; .25 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.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older. Clindamycin phosphate and tretinoin gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years and older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Clindamycin phosphate and tretinoin gel should be applied once daily in the evening, gently rubbing the medication to lightly cover the entire affected area. Approximately a pea-sized amount will be needed for each application. Avoid the eyes, lips, and mucous membranes.
Clindamycin phosphate and tretinoin gel is not for oral, ophthalmic, or intravaginal use. Apply a pea-sized amount once daily in the evening lightly covering the entire affected area. Avoid the eyes, lips, and mucous membranes.
( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Clindamycin phosphate and tretinoin gel, 1.2%/0.025%, containing clindamycin phosphate 1.2% and tretinoin 0.025%, is a yellow, opaque topical gel. Each gram of clindamycin phosphate and tretinoin gel, 1.2%/0.025% contains, as dispensed, 10 mg (1%) clindamycin as clindamycin phosphate, and 0.25 mg (0.025%) tretinoin solubilized in an aqueous-based gel. Topical gel: clindamycin phosphate 1.2% and tretinoin 0.025% in 30-gram and 60-gram tubes.
( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. Clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Colitis: Clindamycin can cause severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of clindamycin. Clindamycin phosphate and tretinoin gel should be discontinued if significant diarrhea occurs.
( 5.1 ) Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. ( 5.2 )
5.1Colitis Systemic absorption of clindamycin has been demonstrated following topical use. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. If significant diarrhea occurs, clindamycin phosphate and tretinoin gel should be discontinued.
Severe colitis has occurred following oral or parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.
Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.
5.2Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be avoided during the use of clindamycin phosphate and tretinoin gel. Patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution.
Daily use of sunscreen products and protective apparel (e.g., a hat) are recommended. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with clindamycin phosphate and tretinoin gel.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Observed local treatment-related adverse reactions (≥ 1%) in clinical studies with clindamycin phosphate and tretinoin gel were application site reactions, including dryness, irritation, exfoliation, erythema, pruritus, and dermatitis. Sunburn was also reported. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solaris Pharma Corporation at 1-833-919-0527 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Adverse Reactions in Clinical Studies Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. The safety data reflect exposure to clindamycin phosphate and tretinoin gel in 1,104 patients with acne vulgaris. Patients were 12 years or older and were treated once daily in the evening for 12 weeks.
Adverse reactions that were reported in ≥1% of patients treated with clindamycin phosphate and tretinoin gel are presented in Table 1 . Table 1: Treatment-Related Adverse Reactions Reported by ≥1% of Patients Clindamycin Phosphate and Tretinoin Gel N = 1,104 n (%) Clindamycin Gel N = 1,091 n (%) Tretinoin Gel N = 1,084 n (%) Vehicle Gel N = 552 n (%) Patients with at least one adverse reaction 140 (13) 38 (3) 141 (13) 17 (3) Application site dryness 64 (6) 12 (1) 62 (6) 3 (1) Application site irritation 50 (5) 4 (<1) 57 (5) 5 (1) Application site exfoliation 50 (5) 2 (<1) 56 (5) 2 (<1) Application site erythema 40 (4) 6 (1) 39 (4) 3 (1) Application site pruritus 26 (2) 7 (1) 23 (2) 6 (1) Sunburn 11 (1) 6 (1) 7 (1) 3 (1) Application site dermatitis 6 (1) 0 (0) 8 (1) 1 (<1) Local skin reactions actively assessed at baseline and end of treatment with a score >0 are presented in Table 2 .
Table 2: Clindamycin Phosphate and Tretinoin Gel - Treated Patients with Local Skin Reactions Clindamycin Phosphate and Tretinoin Gel Vehicle Gel Local Reaction Baseline N = 476 (%) End of Treatment N = 409 (%) Baseline N = 219 (%) End of Treatment N = 209 (%) Erythema 24% 21% 31% 35% Scaling 8% 19% 14% 12% Dryness 11% 22% 18% 13% Burning 8% 13% 8% 4% Itching 17% 15% 22% 14% During the 12 weeks of treatment, each local skin reaction peaked at Week 2 and gradually reduced thereafter.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Clindamycin phosphate and tretinoin gel should not be used in combination with erythromycin-containing products because of its clindamycin component. ( 7.1 )
7.1Erythromycin Clindamycin phosphate and tretinoin gel should not be used in combination with erythromycin-containing products due to possible antagonism to the clindamycin component. In vitro studies have shown antagonism between these 2 antimicrobials. The clinical significance of this in vitro antagonism is not known.
7.2Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, clindamycin phosphate and tretinoin gel should be used with caution in patients receiving such agents.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use: The efficacy and safety have not been established in pediatric patients below the age of 12 years. ( 8.4 )
8.1Pregnancy Pregnancy Category C. There are no well-controlled studies in pregnant women treated with clindamycin phosphate and tretinoin gel. Clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
A limit teratology study performed in Sprague Dawley rats treated topically with clindamycin phosphate and tretinoin gel or 0.025% tretinoin gel at a dose of 2 mL/kg during gestation days 6 to 15 did not result in teratogenic effects. Although no systemic levels of tretinoin were detected, craniofacial and heart abnormalities were described in drug-treated groups. These abnormalities are consistent with retinoid effects and occurred at 16 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison.
For purposes of comparison of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of clindamycin phosphate and tretinoin gel applied daily to a 50-kg person. Clindamycin: Reproductive developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (480 and 240 times the recommended clinical dose based on body surface area comparison, respectively) or subcutaneous doses of clindamycin up to 180 mg/kg/day (140 and 70 times the recommended clinical dose based on body surface area comparison, respectively) revealed no evidence of teratogenicity.
Tretinoin: Oral tretinoin has been shown to be teratogenic in mice, rats, hamsters, rabbits, and primates. It was teratogenic and fetotoxic in Wistar rats when given orally at doses greater than 1 mg/kg/day (32 times the recommended clinical dose based on body surface area comparison). However, variations in teratogenic doses among various strains of rats have been reported.
In the cynomologous monkey, a species in which tretinoin metabolism is closer to humans than in other species examined, fetal malformations were reported at oral doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (324 times the recommended clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related teratogenic effects and increased abortion rates were reported in pigtail macaques. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone.
Thirty cases of temporally associated congenital malformations have been reported during 2 decades of clinical use of another formulation of topical tretinoin. Although no definite pattern of teratogenicity and no causal association have been established from these cases, 5 of the reports describe the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to fetus is not known.
8.3Nursing Mothers It is not known whether clindamycin is excreted in human milk following use of clindamycin phosphate and tretinoin gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
It is not known whether tretinoin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when clindamycin phosphate and tretinoin gel is administered to a nursing woman.
8.4Pediatric Use Safety and effectiveness of clindamycin phosphate and tretinoin gel in pediatric patients below the age of 12 years have not been established. Clinical…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C. There are no well-controlled studies in pregnant women treated with clindamycin phosphate and tretinoin gel. Clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
A limit teratology study performed in Sprague Dawley rats treated topically with clindamycin phosphate and tretinoin gel or 0.025% tretinoin gel at a dose of 2 mL/kg during gestation days 6 to 15 did not result in teratogenic effects. Although no systemic levels of tretinoin were detected, craniofacial and heart abnormalities were described in drug-treated groups. These abnormalities are consistent with retinoid effects and occurred at 16 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison.
For purposes of comparison of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of clindamycin phosphate and tretinoin gel applied daily to a 50-kg person. Clindamycin: Reproductive developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (480 and 240 times the recommended clinical dose based on body surface area comparison, respectively) or subcutaneous doses of clindamycin up to 180 mg/kg/day (140 and 70 times the recommended clinical dose based on body surface area comparison, respectively) revealed no evidence of teratogenicity.
Tretinoin: Oral tretinoin has been shown to be teratogenic in mice, rats, hamsters, rabbits, and primates. It was teratogenic and fetotoxic in Wistar rats when given orally at doses greater than 1 mg/kg/day (32 times the recommended clinical dose based on body surface area comparison). However, variations in teratogenic doses among various strains of rats have been reported.
In the cynomologous monkey, a species in which tretinoin metabolism is closer to humans than in other species examined, fetal malformations were reported at oral doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (324 times the recommended clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related teratogenic effects and increased abortion rates were reported in pigtail macaques. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone.
Thirty cases of temporally associated congenital malformations have been reported during 2 decades of clinical use of another formulation of topical tretinoin. Although no definite pattern of teratogenicity and no causal association have been established from these cases, 5 of the reports describe the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to fetus is not known.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of clindamycin phosphate and tretinoin gel in pediatric patients below the age of 12 years have not been established. Clinical trials of clindamycin phosphate and tretinoin gel included 2,086 patients aged 12 - 17 years of age with acne vulgaris. [See Clinical Studies ( 14 ).]
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of clindamycin phosphate and tretinoin gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Clindamycin: [See Microbiology ( 12.4 ).] Tretinoin: Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedone formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.
12.3Pharmacokinetics In an open-label study of 17 patients with moderate-to-severe acne vulgaris, topical administration of approximately 3 grams of clindamycin phosphate and tretinoin gel once daily for 5 days, clindamycin concentrations were quantifiable in all 17 patients starting from 1 hour post-dose. All plasma clindamycin concentrations were ≤5.56 ng/mL on Day 5, with the exception of 1 subject who had a maximum clindamycin concentration of 8.73 ng/mL at 4 hours post-dose. There was no appreciable increase in systemic exposure to tretinoin, as compared with the baseline value.
The average tretinoin concentration across all sampling times on Day 5 ranged from 1.19 to 1.23 ng/mL compared with the corresponding baseline mean tretinoin concentration range of 1.16 to 1.30 ng/mL.
12.4Microbiology No microbiology studies were conducted in the clinical trials with this product. Mechanism of Action: Clindamycin binds to the 50S ribosomal subunit of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis. Clindamycin has been shown to have in vitro activity against Propionibacterium acnes (P. acnes) , an organism that has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical studies with clindamycin phosphate and tretinoin gel.
P. acnes resistance to clindamycin has been documented. Inducible Clindamycin Resistance: The treatment of acne with antimicrobials is associated with the development of antimicrobial resistance in P. acnes as well as other bacteria (e.g., Staphylococcus aureus, Streptococcus pyogenes ). The use of clindamycin may result in developing inducible resistance in these organisms.
This resistance is not detected by routine susceptibility testing. Cross Resistance: Resistance to clindamycin is often associated with resistance to erythromycin.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Clindamycin: [See Microbiology ( 12.4 ).] Tretinoin: Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedone formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Clindamycin phosphate and tretinoin gel, 1.2%/0.025% is supplied as follows: 30 g aluminum tubes NDC 73473-306-30 60 g aluminum tubes NDC 73473-306-60 Storage and Handling Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). Protect from heat. Protect from light. Protect from freezing. Keep out of reach of children. Keep tube tightly closed.
📋 Description ▾
11 DESCRIPTION Clindamycin phosphate and tretinoin gel, 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).
The structural formula for clindamycin phosphate is represented below: Molecular Formula: C 18 H 34 ClN 2 O 8 PS Molecular Weight: 504.97 The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below: Molecular Formula: C 20 H 28 O 2 Molecular Weight: 300.44 Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine. structure1 structure2
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Patient Information ). Instructions for Use At bedtime, the face should be gently washed with a mild soap and water. After patting the skin dry, apply clindamycin phosphate and tretinoin gel as a thin layer over the entire affected area (excluding the eyes and lips).
Patients should be advised not to use more than a pea-sized amount to cover the face and not to apply more often than once daily (at bedtime) as this will not make for faster results and may increase irritation. A sunscreen should be applied every morning and reapplied over the course of the day as needed. Patients should be advised to avoid exposure to sunlight, sunlamp, ultraviolet light, and other medicines that may increase sensitivity to sunlight.
Other topical products with a strong drying effect such as abrasive soaps or cleansers may cause an increase in skin irritation with clindamycin phosphate and tretinoin gel. Skin Irritation Clindamycin phosphate and tretinoin gel may cause irritation such as erythema, scaling, itching, burning, or stinging. Colitis In the event a patient treated with clindamycin phosphate and tretinoin gel experiences severe diarrhea or gastrointestinal discomfort, clindamycin phosphate and tretinoin gel should be discontinued and a physician should be contacted.
Manufactured for: Solaris Pharma Corporation Bridgewater, NJ 08807