TWYNEO

/ Sol-Gel Technologies Ltd

Apply a thin layer of This medical product 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. This medical product is for topical use only. This medical product is not for oral, ophthalmic, or intravaginal use.

Topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.

* Hypersensitivity to the active substances or to any of the excipients.
* Pregnancy

Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with the use of benzoyl peroxide products. If a serious hypersensitivity reaction occurs, discontinue immediately and initiate appropriate therapy.
Skin Irritation: Patients may experience application site dryness, pain, exfoliation, erythema, dermatitis, pruritus, and irritation. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of the application, or discontinue use. Avoid application of this medical product to cuts, abrasions, eczematous, or sunburned skin.
Photosensitivity: May increase sensitivity to ultraviolet light. Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using this medical product. Instruct patients to implement sun protection measures (e.g., sunscreen and loose-fitting clothes) when sun exposure cannot be avoided.
Discontinue at the first evidence of sunburn.
See prescribing information for full details.

Main adverse effects reported at the application site: pain, dryness, exfoliation, erythema, dermatitis, pruritus, irritation.
See prescribing information for full details.

Pregnancy: This medical product is contraindicated during pregnancy.
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 this medical product use in pregnant women.
There are reports of major birth defects reported with maternal use of topical tretinoin similar to those seen
in infants exposed to oral retinoids, but these case reports do not establish a pattern or association with tretinoin-related embryopathy
Lactation: There are no data on the presence of benzoyl peroxide and tretinoin or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. It is not known whether topical administration of tretinoin could result in sufficient systemic absorption to produce detectable concentrations in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this medical product and any potential adverse effects on the breastfed child from the medical product or from the underlying maternal condition.
See prescribing information for full details.