Banophen (diphenhydramine) Cream

Manufacturer MAJOR Active Ingredient Diphenhydramine (Topical)(dye fen HYE dra meen) Pronunciation DYE fen HYE dra meen
It is used to relieve itching and pain from insect bites or skin irritation.
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Drug Class
Topical Antihistamine; Topical Anesthetic; Antipruritic
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Pharmacologic Class
H1-receptor antagonist (topical)
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Pregnancy Category
Category B (for systemic diphenhydramine; topical absorption is minimal)
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Banophen Cream is a medicine applied to the skin to help relieve itching and pain from insect bites, minor skin irritations, and rashes. It works by blocking certain natural substances in your body that cause itching and by numbing the skin.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.

Apply this medication to your skin only, avoiding the mouth, nose, and eyes, as it may cause burning.
Before and after applying the medication, wash your hands thoroughly, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication and ensure it is completely dry.
Gently rub a thin layer of the medication onto the affected skin.

Important Safety Precautions

Some medications in this class may be flammable, so it is crucial to avoid using them near open flames or while smoking.

Storage and Disposal

To maintain the medication's effectiveness and safety:

Store it at room temperature in a dry place, avoiding bathrooms and areas with high heat.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. You may also want to check with your pharmacist about potential drug take-back programs in your area.

Missed Dose Instructions

If you use this medication on a regular basis and miss a dose:

Apply the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses.

If you use this medication as needed, follow your doctor's instructions and do not use it more frequently than recommended.
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Lifestyle & Tips

  • Clean and dry the affected area before applying the cream.
  • Do not apply to large areas of the body or to broken, blistered, or oozing skin.
  • Avoid contact with eyes, nose, mouth, or other mucous membranes.
  • Do not bandage the treated area tightly.
  • Keep out of reach of children.
  • If using on children, supervise application to ensure proper use and avoid accidental ingestion.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply to affected area not more than 3 to 4 times daily.

Condition-Specific Dosing:

generalUse: Apply a thin layer to the affected skin area.
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Pediatric Dosing

Neonatal: Not established (consult physician)
Infant: Not established (consult physician for children under 2 years)
Child: Children 2 to under 12 years: Apply to affected area not more than 3 to 4 times daily. Consult a physician for use in children under 2 years.
Adolescent: Adolescents 12 years and older: Apply to affected area not more than 3 to 4 times daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

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Mechanism of Action

Diphenhydramine is an antihistamine that acts as a competitive antagonist of H1 histamine receptors. When applied topically, it exerts a local anesthetic effect by blocking nerve impulse transmission, which helps to relieve pain and itching associated with minor skin irritations, insect bites, and rashes. Its antihistaminic action also contributes to reducing the inflammatory response.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible systemic absorption from intact skin; increased absorption possible from abraded or damaged skin.
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not applicable (minimal systemic absorption)
ProteinBinding: Not applicable (minimal systemic absorption)
CnssPenetration: No (minimal systemic absorption)

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Not applicable (minimal systemic absorption)
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Within minutes (for local anesthetic/antipruritic effect)
PeakEffect: Within 15-30 minutes
DurationOfAction: Approximately 2-4 hours

Safety & Warnings

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Side Effects

Important Side Effects to Report Immediately

Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:

Skin irritation

Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of symptoms
  • Symptoms lasting more than 7 days
  • Development of new rash or irritation
  • Signs of infection (e.g., pus, fever, spreading redness)
  • Allergic reaction (e.g., severe rash, hives, difficulty breathing - seek immediate medical attention)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If a large area of your body needs to be treated with this medication.

To ensure safe use, it is crucial to discuss the following with your doctor and pharmacist:

All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems you have.

This information will help your doctor and pharmacist determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To avoid potential interactions, do not use this drug in conjunction with other products that contain diphenhydramine. Before applying this medication, consult your doctor if the affected area has open wounds, severe skin irritation, chickenpox, measles, or blisters. If this medication is ingested, it may cause harm, so it is crucial to contact a doctor or poison control center immediately if swallowing occurs. Note that different brands of this medication may be suitable for children of varying ages, so it is necessary to consult with your doctor before administering this drug to a child. If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical use unless ingested or applied excessively to large areas of broken skin.
  • If ingested, symptoms may include drowsiness, dizziness, confusion, dry mouth, blurred vision, difficulty urinating, or in severe cases, seizures, hallucinations, or coma.

What to Do:

If accidental ingestion occurs, or if symptoms of systemic overdose appear, seek immediate medical attention. Call a Poison Control Center at 1-800-222-1222.

Drug Interactions

Monitoring

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Routine Monitoring

Resolution of symptoms (itching, irritation)

Frequency: Daily, as needed

Target: Reduction or elimination of discomfort

Action Threshold: If symptoms worsen or persist for more than 7 days, discontinue use and consult a healthcare professional.

Local skin reactions (redness, swelling, rash)

Frequency: With each application

Target: Absence of new or worsening skin irritation

Action Threshold: If irritation, rash, or allergic reaction occurs, discontinue use.

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Symptom Monitoring

  • Itching
  • Skin irritation
  • Redness
  • Swelling
  • Rash
  • Pain

Special Patient Groups

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Pregnancy

Generally considered low risk for topical use due to minimal systemic absorption. However, consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Low risk (minimal systemic absorption)
Second Trimester: Low risk (minimal systemic absorption)
Third Trimester: Low risk (minimal systemic absorption)
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Lactation

Generally considered low risk for topical use due to minimal systemic absorption. Avoid applying to areas where the infant may come into direct contact or ingest the cream.

Infant Risk: Low risk (minimal transfer into breast milk from topical application)
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Pediatric Use

Not for use in children under 2 years of age unless directed by a physician. Use with caution in children, as they may be more susceptible to systemic effects if significant absorption occurs (e.g., from large areas of broken skin).

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Geriatric Use

Generally safe for use in the elderly. No specific dose adjustments are typically needed due to minimal systemic absorption.

Clinical Information

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Clinical Pearls

  • Topical diphenhydramine is intended for temporary relief of minor itching and pain. It is not for chronic skin conditions or widespread rashes.
  • Avoid using this product on large areas of the body or on broken, blistered, or oozing skin, as this can increase systemic absorption and potential for side effects.
  • Do not use with other products containing diphenhydramine (oral or topical) to avoid additive systemic effects.
  • If symptoms do not improve within 7 days or worsen, discontinue use and consult a healthcare professional.
  • Photosensitivity can occur with systemic diphenhydramine; while rare with topical use, advise patients to avoid excessive sun exposure on treated areas.
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Alternative Therapies

  • Topical pramoxine (local anesthetic)
  • Topical lidocaine (local anesthetic)
  • Topical corticosteroids (e.g., hydrocortisone for inflammation and itching)
  • Oral antihistamines (for widespread itching, but may cause drowsiness)
  • Colloidal oatmeal baths
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Cost & Coverage

Average Cost: Varies, typically $5-$15 per 1 oz (28g) tube
Generic Available: Yes
Insurance Coverage: OTC (Over-The-Counter), generally not covered by insurance unless prescribed or part of an FSA/HSA plan.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.