# Agency Night Renew Rx Important Safety Information > It is important to inform your dermatology provider of any medical conditions you may have along with any medications you may be taking This medication ha Source: https://support.withagency.com/en_us/agency-night-renew-rx-important-safety-information-HyP97R0fp Last updated: 2026-08-22T14:32:43.721Z **Please read this first: Agency Night Renew Rx is a compounded prescription medication** **Agency Night Renew Rx is a compounded prescription medication.** It is prepared for you by a state-licensed compounding pharmacy operating under Section 503A of Federal Food, Drug & Cosmetic Act (“Section 503A”), pursuant to a prescription drug order issued by your prescribing licensed medical provider for a determined clinical need. **Compounded prescription medications are not FDA-approved.** The FDA has not evaluated Agency Night Renew Rx for safety or efficacy through its drug approval process. Agency Night Renew Rx’s combination of ingredients each individually comply with Section 503A, but the combination compounded medication has not been evaluated or approved by the FDA for safety and efficacy. Agency makes no claims of safety and efficacy with respect to Agency Night Renew Rx. **There is no single, fixed formula.** The active pharmaceutical ingredients (APIs) and strengths in Agency Night Renew Rx are determined by a prescribing licensed medical provider after an appropriate medical evaluation and patient consultation based on skin needs, skincare goals, medical history, and medical exam. Prescription formulas may be different from one patient to another, and they may change over time.  **What Agency Night Renew Rx is for** Agency Night Renew Rx is a personalized compounded prescription drug treatment that aims to target skin concerns such as fine lines, texture, uneven tone, redness, and loss of firmness.  _Results may vary. Product and ingredients are subject to medical evaluation and patient consultation whereby the medical provider determines the compounded prescription medication is appropriate for use._ **Before you start** Consult with your dermatology medical provider about any medical conditions and all medications you are taking before using this compounded prescription medication. Agency Night Renew Rx will be assigned a beyond use date in accordance with Section 503A and United States Pharmacopeia (USP) standards. Do not use this medication after the date listed on the prescription label. **Who should not use Agency Night Renew Rx** If you are currently pregnant, breastfeeding, or trying to get pregnant do not use tretinoin-containing or estriol-containing compounded prescription medications. Estriol is a topical estrogen. Do not use an estriol-containing formula, and tell your medical provider, if any of the following apply to you: * You were assigned male at birth. Estriol-containing formulas are prescribed for cisgender females only. * You are trying to conceive, pregnant, or nursing. * You have or have ever had breast cancer, or breast cancer is suspected. * You have or have had an estrogen-dependent cancer, such as endometrial (uterine) or ovarian cancer. * You have undiagnosed abnormal vaginal bleeding. * You have or have had a blood clot or clotting disorder, including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, or heart attack. * You have a history of a thrombophilic (clotting) disorder, such as protein C, protein S, or antithrombin deficiency. * You have active liver disease, or you have had jaundice (yellowing of the skin or eyes) while using hormones. * You are currently taking tamoxifen, raloxifene, or an aromatase inhibitor. * You have had an allergic or hypersensitivity reaction to estrogen or another hormonal therapy. * You have melasma. Estrogen can worsen hyperpigmentation. * You have certain autoimmune disorders — ask your provider whether yours applies. Yearly pelvic exam, breast exam, and mammogram, and annual OB/GYN visits are recommended. **Active pharmaceuticals ingredients (APIs) that may be in your Agency Night Renew Rx formula compounded prescription medication** The APIs in your Agency Night Renew Rx are selected and prescribed by your state-licensed prescribing medical provider, so your compounded prescription medication may contain some, but not all the APIs listed below. Prescription drug products and APIs are subject to medical consultation. The APIs used within your compounded prescription medication will be listed on your Night Renew Rx bottle label in accordance with state and federal law. Consult your prescribing medical provider if you have questions about the APIs included within your compounded prescription medications. Please inform your medical provider of all allergies, including allergies to ingredients that may be in the Agency Night Renew Rx. These may include: * Azelaic Acid * Dexpanthenol * Estriol * Glycerin * Niacinamide * Tranexamic Acid * Tretinoin **Base inactive ingredients in Agency Night Renew Rx** The base ingredients for each Night Renew Rx compounded prescription medication include: Aloe Barbadensis Leaf Juice, C 13-14 Isoparaffin, Caprylic/Capric Triglyceride, Deionized Water, Laureth-7, Phenoxyethanol, Polyacrylamide, Tocopheryl Acetate, Triethylene Glycol. Night Renew Rx formulas that contain dexpanthenol and/or niacinamide also contain propylene glycol. **Please review the base ingredients if you have allergies, as we do not screen for allergies to the product base.** Agency Night Renew Rx compounded prescription medication that contain estriol are not recommended for use in patients younger than 18 years of age.  **Warnings** Skin irritation may occur as a side effect of this medication. This can include burning, stinging, inflammation, skin peeling, dryness, redness, itching, and increased sensitivity to the sun. Please contact your medical provider if this occurs. To reduce the risk of skin irritation, avoid other products that may irritate the skin. This includes the use of abrasive soaps, exfoliants, and related chemicals or obtaining facial treatments including but not limited to waxing and electrolysis. Further suggestions that may help minimize dryness/irritation include waiting at least 10-20 minutes after washing your face before applying your formula and applying the medication to start every other night and slowly increasing frequency as tolerated. Formulas containing tretinoin may cause you to be more sensitive to the sun. A broad-spectrum sunscreen product with at least SPF 30 should be used daily. Stop treatment if you experience a sunburn. **Estriol-containing formulas:** estriol is a topical estrogen. When applied topically as directed, absorption into the bloodstream is expected to be minimal. Apply only to the area your prescribing medical practitioner directs, use only the amount prescribed, and do not apply estriol-containing formulas to other areas of the body or to hair-bearing areas such as the hairline or eyebrows. Do not cover, wrap, or bandage the treated area. Estrogen can worsen certain types of hyperpigmentation, and darkening of the skin similar to melasma has been reported with topical estrogens. Using this compounded prescription medication for anti-aging purposes is an off-label use of estriol. Contact your prescribing medical practitioner right away if you develop unexpected vaginal bleeding while using an estriol-containing formula, and tell every medical provider who cares for you that you are using a topical estrogen. **Please tell your medical provider if** * You have a personal or family history of breast cancer, ovarian cancer, or uterine cancer. * You have a personal or family history of blood clots, stroke, or heart attack, or a clotting disorder. * You have liver disease, or you have had jaundice while using hormones. * You are using any other hormone therapy, or taking tamoxifen, raloxifene, or an aromatase inhibitor. * You have melasma or another pigmentation condition. **Common side effects** Dry skin or peeling may occur. Some ingredients cannot be used if pregnant or breastfeeding. Do not use Agency Night Renew Rx if allergic to any ingredients or if an allergic reaction occurs. If your formula of Night Renew contains estriol, local side effects may include redness, itching, and burning or stinging at the application site, and hyperpigmentation or melasma-like darkening of the skin. Less common but serious side effects have been reported with systemic estrogen therapy, including heart attack, stroke, blood clots, cancer of the uterus, cancer of the ovary, gallbladder disease, increased triglycerides, liver problems, fluid retention, dementia, and swelling of the face and tongue (angioedema). Oral Estrogen-alone therapy has also been associated with headaches, breast pain and tenderness, unusual vaginal bleeding, vaginal yeast infections, nausea, and vomiting. Stop use and contact your prescribing medical practitioner if you experience any of these symptoms. Do not use if you are allergic to this compounded prescription medication or any of its ingredients. Stop use and contact your healthcare provider right away if you develop symptoms of an allergic reaction such as rash, hives, itching, shortness of breath, wheezing, cough, or swelling of your face, lips, tongue, or throat. **Please tell your medical provider if** * You are pregnant, breastfeeding, or trying to get pregnant. * You are using any products with retinoids (Vitamin A derivatives). Examples may include Adapalene, Epiduo®, Retinol, Tazorac®, etc. * You have had any allergic reactions to skin care products. * If you have been diagnosed with rosacea. * If you have a history of eczema, perioral dermatitis, skin cancer, or other skin conditions. * You are taking any other medications that make you more sensitive to sunlight. **How to use** This compounded prescription medication treatment was designed to be applied once daily in the evening. Apply one pump to clean, dry facial skin, and use no more than two pumps. Do not use more than your prescribing medical provider has instructed you to use. Do not swallow and avoid sensitive areas such as eyes, lips, and inside your mouth/nose. Avoid mucous membranes, hair-bearing areas such as the hairline and eyebrows, and broken skin. Do not use on the body if your Night Renew Rx contains estriol. Do not use on cuts, scrapes, damaged (broken/chapped/cut/irritated/scraped) skin, recently shaved areas of the skin, or sunburned skin. Doing any of these things may increase the chance of undesirable side effects. Please always follow your prescribing medical provider’s specific directions on how to use your Agency Night Renew Rx. **Important summary** This page does not list every possible risk, side effect, warning, or interaction associated with Agency Night Renew Rx, and it is not a substitute for a full consultation and patient counseling with your prescribing medical prescriber. Your prescribing medical prescriber knows your medical history and prescribed the compounded prescription medication specifically to meet your clinical needs. Talk with your prescribing medical provider before you start, stop, or change how you use this compounded prescription medication, and tell them about all of your medical conditions and allergies, and all medications and supplements you take, including over-the-counter products. **Reporting a side effect** If you experience a side effect, contact your Agency prescribing medical provider through your account. If you think you are having a medical emergency, call 911 or go to the nearest emergency room. **Who compounds this medication:** Agency Night Renew Rx is compounded and dispensed by Personalized Skin Solutions, Inc., a state-licensed compounding pharmacy operating in compliance with Section 503A located at 155 Solar Drive, Imperial, PA 15126 (1-888-210-4777). Agency does not manufacture or compound this medication. Questions about how your prescription was compounded, or about your specific ingredient list, can be directed to your medical provider through your account or the pharmacy at the number above.