SkinMedica is a physician-dispensed, cosmetic, and non-prescription skin care product line.
Most SkinMedica products are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA and the statements have not been evaluated by the FDA.
SkinMedica® Total Defense + Repair Broad Spectrum Sunscreens (SPF 34,
SPF 34 Tinted,
Essential Defense Broad Spectrum Sunscreens (Everyday Clear SPF 47,
Mineral Shield Tinted SPF 32,
Mineral Shield SPF 35)
Are over -the-counter drug products which are formulated and marketed pursuant to FDA’s governing regulations set forth at 21 C.F.R. Part 352.
SkinMedica® Purifying Foaming Wash is an over-the-counter drug product which is formulated and marketed pursuant to FDA’s governing regulations set forth at 21 C.F.R. Part 333 Subpart D.
LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
LATISSE® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness.
IMPORTANT SAFETY INFORMATION
Contraindications: LATISSE® is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients.
Warnings and Precautions: In patients using LUMIGAN® (bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use of LATISSE® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN® for IOP reduction should only use LATISSE® after consulting with their physician and should be monitored for changes to their intraocular pressure.
Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation, which is likely to be permanent.
Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients.
There is the potential for hair growth to occur in areas where LATISSE® solution comes in repeated contact with skin surfaces. Apply LATISSE® only to the skin of the upper eyelid margin at the base of the eyelashes.
LATISSE® solution should be used with caution in patients with active intraocular inflammation (eg, uveitis) because the inflammation may be exacerbated. LATISSE® should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
Adverse Reactions: The most frequently reported adverse reactions were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and periorbital erythema. These reactions occurred in less than 4% of patients.