Important Safety Information for Custom Rx Skincare
Custom Rx is a compounded prescription drug. Compounded drugs are permitted to be prescribed under federal law, but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review.
Topical Tretinoin
Topical Azelaic acid
Important Safety Information for Tretinoin
What is the FDA-approved use of tretinoin?
Tretinoin is a topical medication that is used to treat acne and to reduce the appearance of fine lines and wrinkles and other signs of photoaging on the face.
Your Ro-affiliated provider may recommend the use of topical tretinoin, in combination with other ingredients in Custom Rx, as a compounded product to treat various skin concerns.
Compounded drugs are permitted to be prescribed under federal law, but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review.
Who should not use tretinoin?
Do not use tretinoin if:
You are allergic to tretinoin.
You are pregnant or breastfeeding, you are trying to get pregnant, or you are unsure whether you are pregnant. When prescribed as an oral medication, tretinoin was associated with miscarriage and birth defects. While there is inconclusive evidence that tretinoin applied topically can cause miscarriage or birth defects, it is best to be cautious. Tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
How should I use tretinoin?
Unless directed otherwise by your provider, use the formula at nighttime before bed (UV light in sun degrades tretinoin). Wash your face using a gentle cleanser and pat dry. Let the skin dry completely before applying the medication. Apply a thin layer to the entire face. Avoid direct contact with your eyes and eyelids (under the eyes is ok). Wash your hands after applying.
Repeat 2–3 times a week as tolerated to begin with, then gradually increase to nightly use, or as directed by your provider.
Avoid exposure to the eyes, including eyelids, mouth, angles of the nose, and mucous membranes. If contact with the eyes occurs, rinse thoroughly with large amounts of water.
People using tretinoin should have an aggressive sun protection regimen including sunscreen (at least SPF 15 for daily wear and at least SPF 30 when spending time in direct sunlight), protective clothing, and sun avoidance whenever possible.
What should I tell my Ro Derm-affiliated provider before using tretinoin?
It’s important to tell your Ro Derm-affiliated provider all of the topical as well as oral medications you are currently using, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements, even if you think they are unrelated to the skin condition being treated.
Tretinoin can make your skin more sensitive to the sun and can cause drying and peeling.
Using tretinoin with other topical drying agents can increase the drying effects of tretinoin. Some topical medications to watch out for include salicylic acid, sulfur, and resorcinol
Some common oral medications that can make your skin more sensitive to the sun, including certain antibiotics and blood pressure medications, might exacerbate any sun sensitivity resulting from tretinoin use.
It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a history of:
Eczema
Sensitivity to the sun or are easily sunburned
Conditions that may increase sensitivity to sunlight. These include systemic lupus erythematosus, cutaneous lupus erythematosus, albinism, and porphyria
Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most serious side effects that I should monitor for when using tretinoin?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These serious side effects are rare, but may occur with tretinoin.
Skin discoloration
Inflammatory reaction with blistering
What are the most common side effects of tretinoin?
There may be some discomfort or peeling during the early days of treatment while your skin is adjusting to tretinoin. If side effects don’t subside within 2 to 4 weeks, or you are not seeing improvement, reach out to your Ro Derm-affiliated provider for guidance.
Dryness
Itching
Burning
Redness
Peeling
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This summary provides basic information about Custom Rx but does not include all information known about this medicine. If you're prescribed Custom Rx, your Ro-affiliated provider will be able to answer questions about side effects before you begin treatment. You should also read the information that comes with your prescription each time your prescription is filled.
Important Safety Information for Azelaic Acid
What is the FDA-approved use of azelaic acid?
Azelaic acid is used on the skin to treat the inflammatory papules (raised red spots) and pustules (small pus-filled bumps) of mild to moderate rosacea and acne.
Your Ro-affiliated provider may recommend the use of topical azelaic acid, in combination with other ingredients in Custom Rx, as a compounded product to treat various skin concerns.
Compounded drugs are permitted to be prescribed under federal law, but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review.
Who should not use azelaic acid?
Do not use azelaic acid if:
You have had an allergic reaction to azelaic acid in the past.
How should I use azelaic acid?
Unless directed otherwise by your provider, use the formula at nighttime before bed.
Wash your face using a gentle cleanser and pat dry. Let the skin dry completely before applying the medication. Apply a thin layer to the entire face. Avoid direct contact with your eyes and eyelids (under the eyes is ok). Wash your hands after applying.
If you have a cold sore (oral herpes), avoid applying the cream to the area of the cold sore. Exacerbations of cold sores have been reported.
Avoid contact with the mouth, eyes, and other mucous membranes. If exposure to the eye occurs, wash with large amounts of water and contact your doctor or nurse practitioner if irritation persists.
What should I tell my provider before using azelaic acid?
It’s important to tell your provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of asthma.
Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most serious side effects that I should monitor for when using azelaic acid?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These serious side effects are rare, but can occur with azelaic acid.
Hypopigmentation: There have been isolated reports of hypopigmentation (skin lightening) with use of azelaic acid.
Eye and mucous membrane irritation: Avoid contact with the eyes and mucous membranes.
Worsening of asthma: If you have asthma and experience any signs of an asthma attack (i.e., shortness of breath, wheezing), stop using the medication and tell your doctor or nurse practitioner.
What are the most common side effects of azelaic acid?
There may be some discomfort or dryness during the early days of treatment while your skin is adjusting to azelaic acid. If side effects don’t subside within 2 to 4 weeks, or you are not seeing improvement, reach out to your Ro-affiliated provider for guidance.
Burning, stinging, tingling
Itching
Dry, flaky, or cracked skin
Redness and irritation
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This summary provides basic information about Custom Rx but does not include all information known about this medicine. If you're prescribed Custom Rx, your Ro-affiliated provider will be able to answer questions about side effects before you begin treatment. You should also read the information that comes with your prescription each time your prescription is filled.