Tretinoin And Benzoyl Peroxide
Generic Name: tretinoin and benzoyl peroxide
Brand Names:
Twyneo
11 DESCRIPTION TWYNEO (tretinoin and benzoyl peroxide) cream is a yellow cream for topical use. Each gram of TWYNEO contains 1 mg (0.1%) of tretinoin and 30 mg (3%) of benzoyl peroxide. Tretinoin is a retinoid and benzoyl peroxide is an oxidizing agent. The chemical name for tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid.
Overview
11 DESCRIPTION TWYNEO (tretinoin and benzoyl peroxide) cream is a yellow cream for topical use. Each gram of TWYNEO contains 1 mg (0.1%) of tretinoin and 30 mg (3%) of benzoyl peroxide. Tretinoin is a retinoid and benzoyl peroxide is an oxidizing agent. The chemical name for tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid.
Uses
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
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 )
Side Effects
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.
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with use of benzoyl peroxide products. ( 4 , 5.1 ) Skin Irritation: Pain, dryness, exfoliation, erythema, and irritation may occur with use of TWYNEO. Avoid application of TWYNEO to cuts abrasions, eczematous or sunburned skin. ( 5.2 ) Photosensitivity : Minimize unprotected exposure to sunlight and sunlamps. Use sunscreen and protective clothing when sun exposure cannot be avoided. ( 5.3 ) 5.1 Hypersensitivity Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with the use of benzoyl peroxide products. 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 )
Pregnancy
8.1 Pregnancy Risk Summary Available data from published observational studies of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Studies conducted with topical benzoyl peroxide have not demonstrated systemic absorption and maternal use is not expected to result in fetal exposure to benzoyl peroxide. There are no data on TWYNEO use in pregnant women.
Storage
30-gram bottle with a pump, NDC 0299-5945-30 Storage and Handling Prior to Dispensing: Store TWYNEO between 2ºC to 8ºC (36ºF to 46ºF) until dispensed to the patient. After Dispensing: Store TWYNEO at room temperature between 20ºC to 25ºC (68ºF to 77ºF). Discard 12 weeks after date of dispensing or 60 days after first opening, whichever is sooner. Do not freeze.
Frequently Asked Questions
What is Tretinoin And Benzoyl Peroxide used for?▼
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 )
What are the side effects of Tretinoin And Benzoyl Peroxide?▼
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.
Can I take Tretinoin And Benzoyl Peroxide during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from published observational studies of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Studies conducted with topical benzoyl peroxide have not demonstrated systemic absorption and maternal use is not expected to result in fetal exposure to benzoyl peroxide. There are no data on TWYNEO use in pregnant women.
What are the important warnings for Tretinoin And Benzoyl Peroxide?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with use of benzoyl peroxide products. ( 4 , 5.1 ) Skin Irritation: Pain, dryness, exfoliation, erythema, and irritation may occur with use of TWYNEO. Avoid application of TWYNEO to cuts abrasions, eczematous or sunburned skin. ( 5.2 ) Photosensitivity : Minimize unprotected exposure to sunlight and sunlamps. Use sunscreen and protective clothing when sun exposure cannot be avoided. ( 5.3 ) 5.1 Hypersensitivity Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with the use of benzoyl peroxide products. 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.