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Diphenhydramine HCl 20 mg/mL/Fluocinonide 3 mg/mL/Pramoxine HCl 10 mg/mL Topical Gel

FDA-approved generic
Dose form
Topical Gel
Active ingredients
Diphenhydramine Hydrochloride
Fluocinonide
Pramoxine Hydrochloride

Diphenhydramine HCl 20 mg is specifically designed to treat inflammatory skin disorders, allergic reactions, and pruritus (itching) associated with eczema, psoriasis, and contact dermatitis.

A semisolid formulation dispensed through a pump mechanism, it facilitates easy and precise application on the skin for targeted treatment or absorption of active ingredients in a gel-like consistency.

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For prescribers
Prescription details
RxThis formula
Dose formSee below
Quantity____
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription detailsOrder form
Controlled substance: e-prescribe (EPCS) from your EHR. Faxed and phoned prescriptions cannot be accepted for this preparation.
Send it from your EHR, or fax to (401) 284-4506. How to e-prescribe this formula
Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.
To prescribe, you must be a verified prescriber.
To prescribe, you must be in a state where we hold an active out-of-state pharmacy license.
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This medication requires a prescription from your doctor

Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.

For prescribersSign in for prescription details and order forms.
Compounded preparations are prepared by Bayview pursuant to a prescription for an individual patient. They are not FDA-approved and have not been evaluated by FDA for safety or effectiveness.
Diphenhydramine Hydrochloride
Fluocinonide
Pramoxine Hydrochloride
Topical Gel

Formula Information

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This topical gel formulation combines the therapeutic benefits of Diphenhydramine HCl, Fluocinonide, and Pramoxine HCl to provide comprehensive relief for various inflammatory and allergic skin conditions. Dispensed through a convenient pump mechanism, the semisolid gel ensures precise and effortless application directly onto the affected areas, optimizing the treatment's efficacy.

Diphenhydramine HCl at a concentration of 20 mg/mL acts as a potent antihistamine that helps alleviate itching and discomfort by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Fluocinonide, included at 3 mg/mL, is a high-potency topical corticosteroid that reduces inflammation, redness, and swelling. By suppressing the inflammatory response, Fluocinonide effectively treats conditions like eczema, psoriasis, and other corticosteroid-responsive dermatoses, providing rapid relief from inflammatory symptoms and aiding in skin healing.

Pramoxine HCl at 10 mg/mL serves as a local anesthetic that temporarily numbs the skin to relieve pain and itching. This component enhances patient comfort by providing immediate symptomatic relief, making it beneficial for conditions that cause significant discomfort, such as insect bites, poison ivy

Drug Interactions

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This topical gel formulation contains Diphenhydramine HCl, Fluocinonide, and Pramoxine HCl, each of which has specific pharmacological actions that can interact with other medications or conditions. Diphenhydramine HCl is an antihistamine that can cause sedation and has anticholinergic properties. When used topically, systemic absorption is minimal, but caution is advised if the patient is concurrently using other sedatives, CNS depressants, or anticholinergic drugs, as these can potentiate sedative effects or anticholinergic side effects such as dry mouth, constipation, or urinary retention.

Fluocinonide is a potent corticosteroid that reduces inflammation and immune responses. Topical application generally limits systemic exposure, but caution is warranted if the patient is using other corticosteroids, either topically or systemically, as this can increase the risk of systemic corticosteroid effects such as adrenal suppression, Cushing's syndrome, or hyperglycemia. Patients with diabetes should be monitored closely, as corticosteroids can affect blood glucose levels.

Pramoxine HCl is a local anesthetic that provides relief from itching and pain. While systemic absorption is low, patients should be advised to avoid concurrent use of other local anesthetics to prevent potential additive effects, which could lead to systemic toxicity. Additionally, patients with a history of sensitivity to local anesthetics should use this formulation with caution.

For patients with pre-existing conditions such as glaucoma, urinary retention, or prostatic hypertrophy, the anticholinergic effects of diphenhydramine may exacerbate these conditions. Similarly, patients with a history of hypersensitivity to any of the active ingredients or excipients in the formulation should avoid use.

Prescribers should consider the cumulative effects of these active ingredients, especially in patients with complex medication regimens or those with underlying health conditions that may be affected by antihistamines, corticosteroids, or local anesthetics. Regular monitoring and patient education on the signs of potential interactions or side effects are essential to ensure safe and appropriate use of this topical gel.

If you have any questions or need further information regarding this formulation and its potential interactions, please reach out to us at Bayview Pharmacy. We are here to assist both patients and healthcare providers in optimizing treatment outcomes.

How Does it Work

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This unique topical gel formulation combines three active ingredients: Diphenhydramine HCl, Fluocinonide, and Pramoxine HCl, each contributing to the treatment of various dermatological conditions. The semisolid gel is dispensed through a pump mechanism, ensuring easy and precise application, which enhances the targeted treatment and absorption of the active ingredients directly into the affected skin areas.

Diphenhydramine HCl, an antihistamine, works by blocking the action of histamine, a substance in the body that causes allergic symptoms. When applied topically, it helps alleviate itching and discomfort associated with allergic skin reactions, insect bites, and minor skin irritations. By reducing the histamine response, Diphenhydramine HCl provides symptomatic relief from itching and helps prevent further irritation caused by scratching.

Fluocinonide is a potent corticosteroid that reduces inflammation, redness, and swelling by inhibiting the release of inflammatory substances in the body. By decreasing the inflammatory response, Fluocinonide helps to alleviate symptoms like redness, swelling, and itching, promoting faster healing of the skin.

Pramoxine HCl is a topical anesthetic that works by numbing the skin, providing temporary relief from pain and itching. It acts on the nerve endings in the skin, blocking the transmission of pain signals to the brain. This makes it particularly useful for conditions that involve significant discomfort or itching, such as minor burns, insect bites, and rashes. By providing a numbing effect, Pramoxine HCl enhances patient comfort and reduces the urge to scratch, which can further irritate the skin.

The gel-like consistency of this formulation allows for smooth application and rapid absorption of the active ingredients into the skin. The pump mechanism ensures that the correct dose is dispensed each time, minimizing waste and ensuring consistent treatment. This formulation is designed to provide comprehensive relief from a variety of dermatological conditions by addressing multiple symptoms simultaneously, such as itching, inflammation, and pain.

By utilizing the synergistic effects of Diphenhydramine HCl, Fluocinonide, and Pramoxine HCl, this formulation targets the underlying causes of discomfort and promotes healing. If you have any questions or need further information about this formulation, please reach out to us at Bayview Pharmacy.

Other Uses

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The Diphenhydramine HCl 20 mg/mL/Fluocinonide 3 mg/mL/Pramoxine HCl 10 mg/mL Topical Gel is a versatile formulation that can be utilized for a variety of off-label uses beyond its primary indications. This semisolid gel, dispensed through a convenient pump mechanism, allows for precise application, making it particularly beneficial for conditions requiring targeted treatment. While the primary use of this formulation is to address inflammatory skin conditions, itching, and pain, its components offer additional therapeutic benefits that can be harnessed for other dermatological and non-dermatological conditions.

This property can be beneficial for patients experiencing localized allergic reactions or those with hypersensitivity to environmental allergens. Fluocinonide, a potent corticosteroid, can be used to manage various inflammatory skin disorders, including psoriasis and eczema, by reducing inflammation and suppressing immune responses. Its anti-inflammatory properties may also be useful in treating localized inflammatory conditions that are not primarily dermatological, such as joint inflammation in small areas, although this should be approached with caution and under medical supervision.

Pramoxine HCl, a topical anesthetic, provides relief from pain and itching by numbing the skin. This makes the gel suitable for use in conditions where pain management is crucial, such as minor burns, abrasions, or post-procedural skin irritation. Additionally, the gel's formulation allows for rapid absorption and onset of action, making it a practical choice for patients requiring quick relief. The combination of these active ingredients in a gel form ensures that the medication remains localized, minimizing systemic absorption and potential side effects.

For prescribers, this formulation offers a customizable approach to patient care, allowing for adjustments in dosage and application frequency based on individual patient needs and response to treatment. It is important to consider the patient's overall health status, potential drug interactions, and specific condition when prescribing this formulation for off-label uses. Patients should be advised to apply the gel sparingly and only to affected areas, avoiding contact with eyes and mucous membranes. As with any medication, monitoring for adverse reactions is essential, and patients should be instructed to report any unexpected side effects to their healthcare provider.

If you have any questions or require further information about the potential uses of this formulation, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to assist you with any inquiries or concerns you may have regarding this or any other compounded medications.

Frequently Asked Questions

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What is the purpose of this compounded topical gel formulation?

This compounded topical gel is designed to deliver a combination of active ingredients—Diphenhydramine HCl, Fluocinonide, and Pramoxine HCl—directly to the skin for targeted treatment of various skin conditions, providing relief from itching, inflammation, and pain.

How should I apply the topical gel?

The gel should be applied to clean, dry skin. Dispense the gel using the pump mechanism and apply a thin layer to the affected area, gently rubbing it in until fully absorbed. Follow your healthcare provider's instructions regarding the frequency and amount of application.

What conditions can this topical gel treat?

This gel is commonly used to treat skin conditions that involve itching, inflammation, and pain, such as eczema, dermatitis, and allergic reactions. Consult your healthcare provider to determine if this formulation is appropriate for your specific condition.

Are there any side effects associated with this topical gel?

Possible side effects may include skin irritation, redness, or a burning sensation at the application site. If you experience severe side effects or an allergic reaction, discontinue use and contact your healthcare provider immediately.

Can I use this gel on broken or damaged skin?

It is generally advised not to apply the gel to broken or damaged skin unless directed by a healthcare provider, as this may increase the risk of irritation or absorption of the active ingredients into the bloodstream.

Is this topical gel safe for children?

Consult your healthcare provider before using this gel on children, as the safety and efficacy may vary based on age and the specific condition being treated.

How should I store the topical gel?

Store the gel at room temperature, away from direct sunlight and moisture. Keep the container tightly closed and out of reach of children and pets.

Can I use this gel with other topical medications?

Before using this gel with other topical medications, consult your healthcare provider to avoid potential interactions or increased risk of side effects.

What should I do if I miss a dose?

If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular application schedule. Do not apply extra gel to make up for a missed dose.

How long does it take to see results from using this gel?

The time it takes to see results can vary depending on the condition being treated and individual response to the medication. Some users may notice improvement within a few days, while others may require longer use. Follow your healthcare provider's guidance on the duration of treatment.

About this compounded preparation

This formulation is compounded by Bayview Pharmacy on a prescriber's order for an individual patient. It is not an FDA-approved drug product, and the FDA has not evaluated it for safety, effectiveness, or manufacturing quality.

The conditions listed on this page are indications prescribers have ordered this preparation for. They are not FDA-approved indications, and listing them is not a statement that this preparation is effective for them.

A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice — discuss your situation with a licensed healthcare provider.

Formulas and/or material listed are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment. Every patient is unique, and formulas should be adjusted to meet their individual needs.

No compounded medications are reviewed by the FDA for safety or efficacy.
For prescribers

How to e-prescribe this formula

Controlled substance: e-prescribe only (EPCS). Faxed, phoned, and handwritten prescriptions cannot be filled. Rhode Island law (R.I. Gen. Laws § 21-28-3.18) requires Schedule II to V prescriptions to be transmitted electronically.
1

Find Bayview in your EHR's pharmacy directory

Search by NCPDP 4106882, or by name and ZIP: Bayview Pharmacy, Warwick, RI 02886. Select it as the destination pharmacy and save it as a favorite. Click any value to copy it.

NCPDP4106882NPI1750455143Address3844 Post Rd, Warwick, RI 02886Phone(401) 284-4505Fax(401) 284-4506
2

Enter the formula as a compound

Compounded preparations have no NDC, so this formula will not appear in your EHR's drug search. Use your system's compound, non-formulary, or free-text prescription entry and name the preparation exactly as written in step 3. If your EHR forces you to pick a listed drug, pick the closest entry for the active ingredient and put the full formula in the prescription body (the Sig or directions field), not in Notes to Pharmacy.

Compounded preparations have no NDC and will not appear in your drug search. For EPCS to validate, select a drug entry your EHR recognizes as controlled, usually the bulk powder entry for the active ingredient (for example Ketamine (bulk) powder, not a branded product), then put the full formula from step 3 in the prescription body. A free-text entry that does not validate as controlled will be rejected by your EPCS module.

3

Copy the prescription details

RxFormula name
Dose formDose form
Quantity________
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription details

Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.

4

Send it

Transmit from your EHR. For this non-controlled preparation we also accept fax to (401) 284-4506 and phoned orders at (401) 284-4505. Order forms are on the formulation pages and in the prescriber portal.

Transmit with two-factor authentication through your EPCS-enabled EHR. No order form is offered for this preparation; e-prescribing guides for our controlled preparations are on the formulation pages.

Do not use Notes to Pharmacy for the formula. Some EHRs keep that field internal and never transmit it. A prescription that arrives without the formula is delayed while we call your office.

Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA; New York is served on a limited basis while nonresident registration is pending. Compounded preparations are not FDA-approved. A valid prescription is required. Full guide, including steps by EHR: How to e-prescribe to Bayview. Questions about this formula: call (401) 284-4505.

Diphenhydramine HCl 20 mg/mL/Fluocinonide 3 mg/mL/Pramoxine HCl 10 mg/mL Topical Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)