Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% 10 mg/g
Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% · GEL · Encube Ethicals, Inc.
Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% is a gel containing clindamycin phosphate and tretinoin gel 1.2%/0.025% at 10 mg/g, taken topical. Manufactured by Encube Ethicals, Inc..
Key Facts
- Brand Name
- Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%
- Generic Name
- Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%
- NDC Code (Product)
21922-050- Manufacturer
- Encube Ethicals, Inc.
- Strength
- 10 mg/g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA216943
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 09/04/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years or 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 or older. (1)
Dosage & 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-size 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)
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)
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) 7.1 Erythromycin 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. 7.2 Neuromuscular 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.
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 Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Adverse 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 with 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 and 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 Subjects Clindamycin Phosphate and Tretinoin…
Frequently Asked Questions
What is Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% used for?
Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% contains Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%. It is a gel taken topical. Consult your doctor for specific uses.
Is Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% a controlled substance?
Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% is not classified as a controlled substance by the DEA.
What is the generic name for Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%?
The generic name for Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% is Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%. There are no other listed brand versions of Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%.
What is the NDC code for Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% 10 mg/g?
The NDC (National Drug Code) for Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% 10 mg/g is 21922-050, listed by Encube Ethicals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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