# Agency Dark Spot 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-dark-spot-rx-important-safety-information-H1jUbQlQ6

Last updated: 2026-08-22T14:32:15.016Z

**Please read this first: Agency Dark Spot Rx is a compounded prescription medication**

**Agency Dark Spot 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 Dark Spot Rx for safety or efficacy through its drug approval process. Agency Dark Spot 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 Dark Spot Rx.

**There is no single, fixed formula.** The active pharmaceutical ingredients (APIs) and strengths in Agency Dark Spot 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. Because of this, the information on this page describes ingredients that may be in the formulas — not every ingredient listed will be in all formulas.

**What Agency Dark Spot Rx is for**

Agency Dark Spot Rx is a personalized compounded prescription drug treatment that aims to target hyperpigmentation, including melasma, sun spots and age spots, and post-inflammatory hyperpigmentation (the dark marks that can remain after skin inflammation).

_Results may vary. Product and ingredients are subject to medical evaluation and patient consultation where the medical provider evaluating you 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 Dark Spot 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 bottle.

**Who should not use Agency Dark Spot Rx**

If you are currently pregnant or breastfeeding, do not use the Agency Dark Spot Rx compounded prescription medication.

If you are trying to get pregnant do not use your formulation of Agency Dark Spot Rx compounded prescription medication if it contains the API hydroquinone.

Do not use a hydroquinone-containing formulation of Agency Dark Spot Rx compounded prescription medication if you have ochronosis (a blue-black or blue-gray darkening of the skin).

Do not use this medication if you are allergic to any of its active or base ingredients.

**Active pharmaceutical ingredients (APIs) that may be in your Agency Dark Spot Rx formula compounded prescription medication**

The APIs in your Agency Dark Spot 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 Dark Spot Rx bottle label in accordance with state and federal law. Ask your 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 Dark Spot Rx. These may include:

*   Hydroquinone
    
*   Kojic Acid
    
*   Azelaic Acid
    
*   Resveratrol
    
*   Epigallocatechin Gallate
    
*   Hydrocortisone
    

**Base inactive ingredients in Agency Dark Spot Rx**

Agency Dark Spot Rx is compounded in two different bases, depending on whether your formula compounded prescription medication contains hydroquinone.

**Formulas containing hydroquinone:** Cyclopentasiloxane, Caprylyl Methicone, Tocopheryl Acetate, Dimethicone Crosspolymer, PEG-12 Dimethicone/PPG-20 Crosspolymer, Dimethicone, Propanediol, and BHT (Butylated Hydroxytoluene).

**Formulas without hydroquinone:** C13-15 Alkane, Caprylyl Methicone, Cyclopentasiloxane, Diethylene Glycol Monoethyl Ether, Dimethicone, Dimethyl Isosorbide, Moringa Oil/Hydrogenated Moringa Oil Esters, Passiflora Edulis Seed Oil, PEG-12 Dimethicone/PPG-20 Crosspolymer, Pentaerythrityl Tetraisostearate, Polysilicone-11, Tocopherol, Tocopheryl Acetate, Propanediol, and BHT (Butylated Hydroxytoluene).

**Please review the base ingredients if you have allergies, as we do not screen for allergies to the product base.**

**Agency Dark Spot Rx compounded prescription medications containing hydroquinone 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, and itching. 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.

It’s possible to unintentionally lighten the skin surrounding your dark spots when treating them with hydroquinone, creating a “halo spot.” It’s usually possible for the skin to return to normal upon stopping the formula, but it may take several months.

When used long-term, there is a small risk that hydroquinone can lead to permanent blue-gray darkening of the skin (ochronosis), so it’s important to follow your prescribing medical provider’s instructions and take breaks from your Dark Spot Rx as directed. Also, note that using a hydroquinone topical together with peroxide products (including but not limited to benzoyl peroxide and hydrogen peroxide) may stain your skin. This staining can usually be removed with soap and water.

Your prescribing medical provider will schedule breaks from hydroquinone as part of your treatment plan. Do not restart or extend hydroquinone use on your own, and contact your provider if you are unsure where you are in your break schedule.

If you notice halo spots forming, dark spots getting darker, or other discoloration, please stop using the formula and let your Agency prescribing medical provider know.

It’s possible, although very rare, to see more serious side effects with long-term topical corticosteroid use, especially at higher strengths. These side effects include skin findings (i.e., striae, telangiectasia and other dilated vessels, and skin atrophy), HPA axis suppression, Cushing syndrome, hyperglycemia, cataracts, glaucoma, and intracranial hypertension. As always, if you notice any unusual symptoms while using the Dark Spot Rx, please stop using it and reach out to your provider for guidance.

If your formula of Agency Dark Spot Rx contains hydrocortisone, limit prolonged use and use it only for as long as your prescribing medical provider directs. If you are using other topical or systemic steroids, please inform your prescribing medical provider.

A broad-spectrum sunscreen product with at least SPF 30 is recommended to be used daily. Dark spots can worsen with sun exposure even with treatment, so it’s important to apply sunscreen consistently.

**Common side effects**

Dry skin or peeling may occur. Some APIs that may potentially be included within your compounded prescription medication cannot be used if pregnant or breastfeeding. Do not use Agency Dark Spot Rx if you are allergic to any ingredients or if an allergic reaction occurs.

Burning, itching, stinging, redness, dryness, and peeling may occur, most often in the first few weeks after starting this medication. Depending on your compounded prescription medication, you may also notice temporary lightening or darkening of the treated skin.

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 or have recently used any products with hydroquinone.
    
*   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 have ochronosis or any other pigmentation disorder.
    
*   You are using any other topical steroid, on your face or elsewhere on your body.
    
*   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 twice daily in the morning and evening. Apply the formula directly to dark spots and patches. Do not use more than your prescribing provider has instructed you to use. Do not swallow and avoid sensitive areas such as eyes, lips, and inside your mouth/nose. 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 Dark Spot Rx.

**Important summary**

This page does not list every possible risk, side effect, warning, or interaction associated with Agency Dark Spot Rx, and it is not a substitute for a full consultation and patient counseling with your prescribing medical provider. Your prescribing medical provider 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 Dark Spot 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.