Twyneo 30 mg/g
Benzoyl Peroxide and Tretinoin · CREAM · Mayne Pharma Commercial LLC
Twyneo is a cream containing benzoyl peroxide and tretinoin at 30 mg/g, taken topical. Manufactured by Mayne Pharma Commercial LLC.
Key Facts
- Brand Name
- Twyneo
- Generic Name
- Benzoyl Peroxide and Tretinoin
- NDC Code (Product)
51862-771- Manufacturer
- Mayne Pharma Commercial LLC
- Strength
- 30 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA214902
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 08/01/2025
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 TWYNEO is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is a combination tretinoin, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply a thin layer of TWYNEO to the affected areas once daily on clean and dry skin. Avoid contact with the eyes, lips, paranasal creases, and mucous membranes. Wash hands after application. TWYNEO is for topical use only. TWYNEO is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of TWYNEO to the affected areas once daily. ( 2 ) Avoid contact with eyes, lips, paranasal creases, and mucous membranes. ( 2 ) Wash hand after application. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )
Contraindications
4 CONTRAINDICATIONS TWYNEO is contraindicated in patients with a history of hypersensitivity reaction to benzoyl peroxide or any components of TWYNEO [see Warnings and Precautions (5.1) ] . History of serious hypersensitivity reaction to benzoyl peroxide or any component of TWYNEO. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥ 1%) are pain, dryness, exfoliation erythema, dermatitis, pruritus and irritation (all at the application site). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical trials experience The following adverse reactions are discussed in greater detail elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1 )] Skin Irritation [see Warnings and Precautions (5.2) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates are 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. In two multicenter, randomized, double-blind, vehicle-controlled trials (Trial 1 and 2), 832 subjects 9 years of age and older with facial acne vulgaris applied TWYNEO (N=555) or vehicle (N=277) daily for 12 weeks. The majority of subjects were White (73%) and female (59%). Approximately 33% were Hispanic/Latino, and 46% were younger than 18 years of age. Adverse react…
Frequently Asked Questions
What is Twyneo used for?
Twyneo contains Benzoyl Peroxide and Tretinoin. It is a cream taken topical. Consult your doctor for specific uses.
Is Twyneo a controlled substance?
Twyneo is not classified as a controlled substance by the DEA.
What is the generic name for Twyneo?
The generic name for Twyneo is Benzoyl Peroxide and Tretinoin. There are no other listed brand versions of Benzoyl Peroxide and Tretinoin.
What is the NDC code for Twyneo 30 mg/g?
The NDC (National Drug Code) for Twyneo 30 mg/g is 51862-771, listed by Mayne Pharma Commercial LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)