Clindamycin Phosphate 1.2% and Tretinoin 0.025% 12 mg/g
clindamycin phosphate and tretinoin · GEL · Oceanside Pharmaceuticals
Clindamycin Phosphate 1.2% and Tretinoin 0.025% is a gel containing clindamycin phosphate and tretinoin at 12 mg/g, taken topical. Manufactured by Oceanside Pharmaceuticals.
Key Facts
- Brand Name
- Clindamycin Phosphate 1.2% and Tretinoin 0.025%
- Generic Name
- clindamycin phosphate and tretinoin
- NDC Code (Product)
68682-300- Manufacturer
- Oceanside Pharmaceuticals
- Strength
- 12 mg/g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA050802
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 08/04/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 & 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 )
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 )
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 ) 7.1 Concomitant 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. 7.2 Erythromycin 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. 7.3 Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, Clinda…
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. 6.1 Clinical 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 i…
Frequently Asked Questions
What is Clindamycin Phosphate 1.2% and Tretinoin 0.025% used for?
Clindamycin Phosphate 1.2% and Tretinoin 0.025% contains clindamycin phosphate and tretinoin. It is a gel taken topical. Consult your doctor for specific uses.
Is Clindamycin Phosphate 1.2% and Tretinoin 0.025% a controlled substance?
Clindamycin Phosphate 1.2% and Tretinoin 0.025% is not classified as a controlled substance by the DEA.
What is the generic name for Clindamycin Phosphate 1.2% and Tretinoin 0.025%?
The generic name for Clindamycin Phosphate 1.2% and Tretinoin 0.025% is clindamycin phosphate and tretinoin. There are 4 other brand versions of clindamycin phosphate and tretinoin.
What is the NDC code for Clindamycin Phosphate 1.2% and Tretinoin 0.025% 12 mg/g?
The NDC (National Drug Code) for Clindamycin Phosphate 1.2% and Tretinoin 0.025% 12 mg/g is 68682-300, listed by Oceanside Pharmaceuticals.