Clindamycin Phosphate 1.2% and Tretinoin 0.025% 12 mg/g; .25 mg/g Gel
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Retinoid class.
Where does this data come from?
🏭 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 | $6.545 | $196.34 / 30 g |
| Medicaid paysCMS SDUD · 12 mo | $5.62 | $168.60 / 30 g |
| 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 |
|---|---|---|---|---|---|---|
| Clindamycin Phosphate and Tretinoin 12 mg/g; .25 mg/g 00472-1790-30 | Actavis | 1 tube | $4.328 | AB1 | Availability likely | save 34% |
| 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 | save 34% |
| Clindamycin Phosphate and Tretinoin 10 mg/g; .25 mg/g 73473-0306-30 | Solaris | 1 tube | $4.328 | AB2 | Availability likely | save 34% |
| Clindamycin Phosphate 1.2% and Tretinoin 0.025% 12 mg/g; .25 mg/gthis 68682-0300-30 | Oceanside | 1 tube | $6.545 | AB1 | FDA listed | — |
| 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
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68682-0300-30 You're viewing this | 1 TUBE in 1 CARTON (68682-300-30) / 30 g in 1 TUBE | $6.54 / g | $196.34 | 2020-08-04 | Active |
| 68682-0300-60 | 1 TUBE in 1 CARTON (68682-300-60) / 60 g in 1 TUBE | — | — | 2020-08-04 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 64% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 68682-0300-30?
What NDC number is used to bill for this package of Clindamycin Phosphate 1.2% and Tretinoin 0.025% 12 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 1.2% and Tretinoin 0.025% Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years or older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION At bedtime, squeeze a pea-sized amount of medication onto one fingertip, dot onto the chin, cheeks, nose, and forehead, then gently rub over the entire face. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is not for oral, ophthalmic, or intravaginal use. • Apply a pea-sized amount to the entire face once daily at bedtime.
Do not apply to eyes, mouth, angles of the nose, or mucous membranes. ( 2 ) • Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is not for oral, ophthalmic, or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel, a combination of a lincosamide antibiotic and a retinoid, contains clindamycin phosphate 1.2% and tretinoin 0.025%, formulated as a topical gel. Each gram of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel contains, as dispensed, 10 mg (1%) clindamycin as phosphate, and 0.25 mg (0.025%) tretinoin in an aqueous-based gel. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is available in 30 gram and 60 gram tubes.
Topical gel: Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel in 30 and 60 gram tubes. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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 1.2% and Tretinoin 0.025% Gel should be discontinued if significant diarrhea occurs.
( 5.1 ) • Ultraviolet Light and Environmental Exposures: Avoid exposure to sunlight and sunlamps. Wear sunscreen daily. ( 5.2 )
5.1Colitis Systemic absorption of clindamycin has been demonstrated following topical use of this product. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. When significant diarrhea occurs, Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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 1.2% and Tretinoin 0.025% Gel, and 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 1.2% and Tretinoin 0.025% Gel.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Observed local adverse reactions in patients treated with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel were skin erythema, scaling, itching, burning, and stinging. Other most commonly reported adverse events (≥1% in patients treated with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel) were nasopharyngitis, pharyngolaryngeal pain, dry skin, cough, and sinusitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use for approximating rates. The safety data presented in Table 1 (below) reflects exposure to Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel in 1853 patients with acne vulgaris.
Patients were 12 years and older and were treated once daily for 12 weeks. Adverse reactions that were reported in ≥1% of patients treated with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel were compared to adverse reactions in patients treated with clindamycin phosphate 1.2% in vehicle gel, tretinoin 0.025% in vehicle gel, and the vehicle gel alone: Table 1: Adverse Reactions Reported in at Least 1% of Patients Treated with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel: 12-Week Studies Clindamycin Phosphate 1.2% and Tretinoin 0.025%Gel N=1853 N (%) Clindamycin N=1428 N (%) Tretinoin N=846 N (%) Vehicle N=423 N (%) PATIENTS WITH AT LEAST ONE AR 497 (27) 342 (24) 225 (27) 91 (22) Nasopharyngitis 65 (4) 64 (5) 16 (2) 5 (1) Pharyngolaryngeal pain 29 (2) 18 (1) 5 (1) 7 (2) Dry skin 23 (1) 7 (1) 3 (<1) 0 (0) Cough 19 (1) 21 (2) 9 (1) 2 (1) Sinusitis 19 (1) 19 (1) 15 (2) 4 (1) NOTE: Formulations used in all treatment arms were in the Clindamycin Phosphate 1.2% and Tretinoin 0.025% vehicle gel.
Cutaneous safety and tolerance evaluations were conducted at each study visit in all of the clinical trials by assessment of erythema, scaling, itching, burning, and stinging: Table 2: Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel-Treated Patients with Local Skin Reactions Local Reaction Baseline N=1835 N (%) End of Treatment N=1614 N (%) Erythema 636 (35) 416 (26) Scaling 237 (13) 280 (17) Itching 189 (10) 70 (4) Burning 38 (2) 56 (4) Stinging 33 (2) 27 (2) At each study visit, application site reactions on a scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe), and the mean scores were calculated for each of the local skin reactions.
In Studies 1 and 2, 1277 subjects enrolled with moderate to severe acne, 854 subjects treated with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel and 423 treated with vehicle. Analysis over the 12-week period demonstrated that cutaneous irritation scores for erythema, scaling, itching, burning, and stinging peaked at 2 weeks of therapy, and were slightly higher for the Clindamycin Phosphate 1.2% and Tretinoin 0.025%-treated group, decreasing thereafter. One open-label 12-month safety study for Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel showed a similar adverse reaction profile as seen in the 12-week studies.
Eighteen out of 442 subjects (4%) reported gastrointestinal symptoms.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Concomitant use of topical medications with a strong drying effect can increase skin irritation. Use with caution. ( 7.1 ) • Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel should not be used in combination with erythromycin-containing products because of its clindamycin component. ( 7.2 )
7.1Concomitant Topical Medication Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution. When used with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel, there may be increased skin irritation.
7.2Erythromycin Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel should not be used in combination with erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known.
7.3Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel should be used with caution in patients receiving such agents.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel was tested for maternal and developmental toxicity in New Zealand White Rabbits with topical doses of 60, 180 and 600 mg/kg/day. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity following dermal administration of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel for 2 weeks prior to artificial insemination and continuing until gestation day 18, inclusive.
For purposes of comparisons of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel applied daily to a 60 kg person. Clindamycin Teratology (Segment II) studies using clindamycin were performed orally in rats (up to 600 mg/kg/day) and mice (up to 100 mg/kg/day) (583 and 49 times amount of clindamycin in the recommended clinical dose based on body surface area comparison, respectively) or with subcutaneous doses of clindamycin up to 180 mg/kg/day (175 and 88 times the amount of clindamycin in the recommended clinical dose based on body surface area comparison, respectively) revealed no evidence of teratogenicity.
Tretinoin In oral Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (~78 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison). 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 two 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, five 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 the fetus is not known. Dermal tretinoin has been shown to be fetotoxic in rabbits when administered in doses 40 times the recommended human clinical dose based on body surface area comparison.
Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 78 times the recommended clinical dose based on body surface area comparison.
8.3Nursing Mothers It is not known whether clindamycin is excreted in human milk following use of Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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 1.2% and Tretinoin 0.025% Gel is administered to a nursing woman.
8.4Pediatric Use Safety and effectiveness of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel in pediatric patients under the age of 12 have not been established. Clinical trials of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel included patients 12-17 years of age. [See Clinical Studie…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel was tested for maternal and developmental toxicity in New Zealand White Rabbits with topical doses of 60, 180 and 600 mg/kg/day. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity following dermal administration of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel for 2 weeks prior to artificial insemination and continuing until gestation day 18, inclusive.
For purposes of comparisons of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel applied daily to a 60 kg person. Clindamycin Teratology (Segment II) studies using clindamycin were performed orally in rats (up to 600 mg/kg/day) and mice (up to 100 mg/kg/day) (583 and 49 times amount of clindamycin in the recommended clinical dose based on body surface area comparison, respectively) or with subcutaneous doses of clindamycin up to 180 mg/kg/day (175 and 88 times the amount of clindamycin in the recommended clinical dose based on body surface area comparison, respectively) revealed no evidence of teratogenicity.
Tretinoin In oral Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (~78 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison). 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 two 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, five 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 the fetus is not known. Dermal tretinoin has been shown to be fetotoxic in rabbits when administered in doses 40 times the recommended human clinical dose based on body surface area comparison.
Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 78 times the recommended clinical dose based on body surface area comparison.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel in pediatric patients under the age of 12 have not been established. Clinical trials of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel included patients 12-17 years of age. [See Clinical Studies (14) .]
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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 microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.
12.3Pharmacokinetics In an open-label, multiple-dose study treating 12 subjects with moderate to severe acne, the percutaneous absorption of tretinoin following 14 consecutive daily applications of approximately 4 g of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel was minimal. Quantifiable tretinoin plasma concentrations ranged from 1.0 to 1.6 ng/mL, with unquantifiable plasma concentrations in 50% to 92% of subjects at any given timepoint following administration. The plasma concentrations of the key tretinoin metabolites, 13-cis-retinoic acid and 4-oxo-13-cis-retinoic acid, ranged from 1.0 to 1.4 ng/mL and from 1.6 to 6.5 ng/mL, respectively.
Plasma concentrations for clindamycin generally did not exceed 3.5 ng/mL, with the exception of one subject whose plasma concentration reached 13.1 ng/mL.
12.4Microbiology Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing bacterial protein synthesis. Clindamycin has been shown to have in vitro activity against Propionibacterium acnes , an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical trials with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel.
P. acnes resistance to clindamycin has been documented. 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 microcomedo 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 Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is supplied as follows: 30 gram tube NDC 68682-300-30 60 gram tube NDC 68682-300-60 Storage and Handling • Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. • Protect from light. • Protect from freezing. • Keep out of the reach of children. • Keep away from heat. • Keep tube tightly closed.
📦 Storage and Handling ▾
Storage and Handling • Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. • Protect from light. • Protect from freezing. • Keep out of the reach of children. • Keep away from heat. • Keep tube tightly closed.
📋 Description ▾
11 DESCRIPTION Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is an antibiotic and retinoid combination gel product with two active ingredients. 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: Clindamycin phosphate: Molecular Formula: C 18 H 34 ClN 2 O 8 PS Molecular Weight: 504.97 The chemical name for tretinoin is 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8 nonatetraenoic acid (all- trans form). The structural formula for tretinoin is represented below: Tretinoin: Molecular Formula: C 20 H 28 O 2 Molecular Weight: 300.44 Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel contains the following inactive ingredients: butylated hydroxytoluene NF, carbomer 981 NF, citric acid USP, edetate disodium USP, glycerin USP, methylparaben NF, polysorbate 80 NF, propylparaben NF, purified water USP and tromethamine USP.
Chemical Structure Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Instructions for Use • At bedtime, the face should be gently washed with a mild soap and warm water. After patting the skin dry, apply Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel as a thin layer over the entire face (excluding the eyes and lips). • Patients should be advised not to use more than the recommended pea-sized amount 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. Skin Irritation Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel may cause irritation such as erythema, scaling, itching, burning, or stinging. Colitis In the event a patient treated with Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel experiences severe diarrhea or gastrointestinal discomfort, Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel should be discontinued and a physician should be contacted.
Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada © 2020 Bausch Health Companies Inc. or its affiliates 9704800