azelaic acid 10%, niacinamide 4%, tretinoin .025%/.05%/.1%

Your Medication May Contain One or More of the Following:

Niacinamide
Also known as nicotinamide, niacinamide is an amide derivative of niacin or vitamin B3. Niacinamide has UV absorptive, antioxidant, anti-inflammatory properties and helps to prevent cell death. It is inferred that the niacin derivatives have photoprotective and anti-skin aging potential via the stimulation of collagen fibers and up-regulation of heat shock proteins, as well as direct antioxidant activity.¹

Retinoic Acid (Tretinoin)
Derived from Vitamin A, the mainstay of topical therapy for intrinsically and extrinsically aged skin is topical retinoids, both natural and synthetic forms. Retinoic acid has been extensively investigated for its effects in aged skin.² Enhances the granulation that occurs during the proliferation stage of wound healing and aids in collagen synthesis. It can also decrease the MMP’s involved in collagen and elastin degradation.³ It can cause loosening and exfoliation of the follicular and epithelial cells in the stratum corneum.

Azelaic Acid
Azelaic acid is a comedolytic, antibacterial (against C. acnes and S. epidermidis) and anti-inflammatory agent. It inhibits the production of free radical oxygen by neutrophils and reduces oxidative tissue injury at sites of inflammation and decreases melanin production. It can be used for post inflammatory hyperpigmentation in acne.^4-5

Hyaluronic Acid
One of the key molecules involved in skin hydration. Over 50% of total body hyaluronic acid is present in skin.⁶ Hyaluronan is a high molecular weight, anionic polysaccharide that promotes cell motility, adhesion, and proliferation processes requiring cell movement and tissue organization. Hyaluronic acid has long standing use in cosmetic preparations to help promote moisture and elasticity of the skin.⁷

Do not use this medication if:

• You are pregnant, planning to become pregnant, or breastfeeding.
• You are allergic to any of the ingredients in your medication. Signs of an allergic reaction may include rash, hives, itching, shortness of breath, swelling of the face, lips, tongue, or throat, wheezing or cough.
• The area of skin where you are applying the medication is sunburned, cut, scraped, or damaged.
• You are sensitive to light or taking medications which cause photosensitivity.
• If the skin irritation worsens or does not go away.
• If you have asthma and it worsens.

When using this product:

• Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
• Avoid tanning beds, sunlamps, skin waxing, and other manipulations to the skin as sensitivity is increased with using this medication.
• Always wear sunscreen/SPF, skin coverings/clothing, and eyewear during the day as this medication can increase your risk of sunburn.
• Do not use other prescription or OTC anti-aging products with this medication without first consulting with your provider.
• Tell your provider of any changes to your medical history or medication list, including herbal and over-the-counter changes.
• If you miss an application, resume the next evening. Do not double applications at the same time.

Stop use and notify a clinician if you experience any of the following:

• Chest pain, rapid heartbeat, faintness, or dizziness.
• Sudden, unexplained weight gain.
• Your hands or feet swell.
• If the skin irritation worsens or does not go away.
• If your asthma worsens.
• You experience unexpected or prolonged irritation or if you have concerns about the listed side effects.

Side effects:

There is a rare chance that a worsening of asthma can occur in asthmatics. Contact your doctor if you experience a worsening of your asthma condition.

Warnings:

• For external use only.
• Wash hands before and after use of this medication.
• Avoid contact with eyes.
• Do not swallow. If swallowed, notify Poison Control.
• Do not use if you are pregnant, planning to become pregnant, or breastfeeding.
• Keep out of reach of children and pets.
• Inform your physician that you are taking this medication.
• Women of child-bearing potential should not handle this medication.
• This medication is designed specifically for you and should not be shared with others.
• Using more medication than prescribed or for longer than indicated will not speed up results and may lead to increased risk of side effects.

Store at Controlled Room Temperature 68° to 77°F (20° to 25°C)

Information contained on this handout is provided as an informational aide and for reference use only. The content herein is not intended to be, act as, or replace medical advice or diagnosis for individual health conditions nor is it making evaluations as to the risks or benefits of compounded preparations. Please consult a licensed healthcare professional about diagnosis and treatment. Information and statements within this handout have not been evaluated by the Food and Drug Administration.


1. Philips N, Chalensouk-Khaosaat J, Gonzalez S. Stimulation of the Fibrillar Collagen and Heat Shock Proteins by Nicotinamide or Its Derivatives in Non-Irradiated or UVA Radiated Fibroblasts, and Direct Anti-Oxidant Activity of Nicotinamide Derivatives. Cosmetics 2015; 2. 146-161.
2. Woodley DT, Zelickson AS, Briggaman RA, et al. Treatment of photoaged skin with topical tretinoin increases epidermal- dermal anchoring fibrils. A preliminary report. JAMA. 1990;263:3057.
3. Fisher GJ, Datta SC, Talwar HS, et al. Molecular basis of sun-induced premature skin ageing and retinoid antagonism. Nature. 1996;379:335.
4. Cunliffe WJ, Holland KT. Clinical and laboratory studies of treatment with 20% azelaic acid cream for acne. Acta Derm Venereol Suppl (Stockh). 1989; 143:31-34.2
5. Katsambas A, Graupe K, Stratigos J. Clinical studies of 20% azelaic acid cream in the treatment of acne vulgaris. Comparison with vehicle and topical tretinoin. Acta Derm Venereol Suppl (Stockh). 1989; 143:35-39.
6. Toole BP. Proteoglycans and hyaluronan in morphogenesis and differentiation. In: Hay ED, ed. Cell Biology of Extracellular Matrix. New York: Plenum Press, 1991: 305–314.
7. Nachbar F, Korting H. The role of vitamin E in normal and damaged skin. J Mol Med (Berl). 1995;73(1):7–17