Zinc Oxide 20% Ointment 28.4gm

Manufacturer NIVAGEN PHARMACEUTICALS Active Ingredient Zinc Oxide Topical Cream, Ointment, and Paste(zink OKS ide) Pronunciation Zink OKS ide
It is used to treat or prevent diaper rash.It is used to treat skin irritation.It is used to treat poison oak, ivy, and sumac rashes.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Skin Protectant
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Pharmacologic Class
Astringent; Barrier Agent
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Pregnancy Category
Category A
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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?

Zinc oxide ointment is a skin protectant that forms a barrier on your skin to help prevent and heal diaper rash, chafing, and other minor skin irritations. It keeps moisture away from the skin and helps it heal.
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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 accompanying information carefully. It is essential to use this medication as directed.

Application Instructions

Apply this medication only to the affected area of your skin. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause irritation or burning.
Before and after applying the medication, wash your hands thoroughly. However, if the treated area is on your hand, do not wash your hand after application.
Clean the affected area before applying the medication and ensure it is completely dry.
Gently rub the medication into the affected area.

Special Considerations

If using this medication on a diapered area, change the diaper frequently to prevent irritation. Clean the affected area, allow it to dry, and reapply the medication with each diaper change, especially at bedtime.

Storage and Disposal

Store this medication at room temperature in a dry location, avoiding bathrooms and areas prone to moisture.
Keep all medications in a secure, inaccessible location to prevent accidental ingestion by children or pets.

Missed Dose

If you miss a dose, apply it as soon as you remember. Since this medication is often used as needed, do not apply it more frequently than prescribed by your doctor.
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Lifestyle & Tips

  • Keep the affected skin area clean and dry before applying the ointment.
  • Change wet or soiled diapers promptly.
  • Allow skin to air dry whenever possible.
  • Avoid tight-fitting clothing or diapers that may cause friction.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply liberally to affected skin as often as needed, especially after each diaper change or bath.

Condition-Specific Dosing:

diaperRash: Apply liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
minorSkinIrritations: Apply as needed to clean, dry skin.
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Pediatric Dosing

Neonatal: Apply liberally to affected skin as often as needed, especially after each diaper change or bath.
Infant: Apply liberally to affected skin as often as needed, especially after each diaper change or bath.
Child: Apply liberally to affected skin as often as needed, especially after each diaper change or bath.
Adolescent: Apply liberally to affected skin as often as needed, especially after each diaper change or bath.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (topical application, minimal systemic absorption).
Moderate: No adjustment needed (topical application, minimal systemic absorption).
Severe: No adjustment needed (topical application, minimal systemic absorption).
Dialysis: No specific considerations (topical application, minimal systemic absorption).

Hepatic Impairment:

Mild: No adjustment needed (topical application, minimal systemic absorption).
Moderate: No adjustment needed (topical application, minimal systemic absorption).
Severe: No adjustment needed (topical application, minimal systemic absorption).

Pharmacology

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Mechanism of Action

Zinc oxide acts as a skin protectant by forming a physical barrier on the skin surface, which prevents irritation from moisture and friction. It also has mild astringent and antiseptic properties, helping to dry oozing and weeping from minor skin irritations and to prevent bacterial growth. It reflects UV radiation, providing some sun protection.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible systemic absorption from intact skin.
Tmax: Not clinically relevant for topical application.
FoodEffect: Not applicable (topical).

Distribution:

Vd: Not clinically relevant due to minimal systemic absorption.
ProteinBinding: Not clinically relevant due to minimal systemic absorption.
CnssPenetration: No (minimal systemic absorption).

Elimination:

HalfLife: Not clinically relevant due to minimal systemic absorption.
Clearance: Not clinically relevant due to minimal systemic absorption.
ExcretionRoute: Not clinically relevant due to minimal systemic absorption.
Unchanged: Not clinically relevant due to minimal systemic absorption.
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Pharmacodynamics

OnsetOfAction: Immediate (barrier effect upon application).
PeakEffect: Immediate (maximum barrier protection upon application).
DurationOfAction: Until removed or worn off (typically with each diaper change or washing).

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or 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, or swelling of the mouth, face, lips, tongue, or throat.

Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice.
It's essential to note that this list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor.
For medical advice about side effects, contact 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:

  • Rash worsens or does not improve within 7 days.
  • Symptoms clear up and then return.
  • Redness, irritation, or swelling increases.
  • You develop a fever.
  • Signs of infection (e.g., pus, severe pain, spreading redness).
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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 symptoms you experienced.
If you have a deep wound or a puncture wound.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not 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 of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the prescribed dosage and duration of treatment, and avoid using this drug more frequently or for a longer period than recommended.

To minimize the risk of staining, take precautions to protect your clothing and fabrics from coming into contact with this medication, as it may cause discoloration.

In the event that this drug is ingested, it can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.

If you are pregnant, planning to become pregnant, or are currently breast-feeding, it is crucial to discuss your situation with your doctor. Your healthcare provider will help you weigh the benefits and risks of taking this medication, considering both your health and the well-being of your baby.
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Overdose Information

Overdose Symptoms:

  • Topical overdose is unlikely to cause systemic toxicity.
  • If ingested in large quantities, symptoms may include nausea, vomiting, diarrhea, abdominal pain, and metallic taste.

What to Do:

For topical overuse, simply wipe off excess. For accidental ingestion, contact a poison control center immediately (Call 1-800-222-1222). Provide supportive care for gastrointestinal symptoms.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition (e.g., presence of rash, irritation, redness, broken skin)

Rationale: To assess the severity of the skin irritation and determine the need for treatment.

Timing: Prior to first application.

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Routine Monitoring

Resolution of symptoms (e.g., decreased redness, healing of rash, reduced irritation)

Frequency: Daily or with each application.

Target: Improvement or resolution of skin irritation.

Action Threshold: If symptoms worsen or do not improve within 7 days, discontinue use and consult a healthcare professional.

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Symptom Monitoring

  • Worsening of rash or irritation
  • Development of new symptoms (e.g., severe pain, blistering, pus)
  • Signs of allergic reaction (e.g., severe itching, swelling, hives)

Special Patient Groups

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Pregnancy

Considered safe for use during pregnancy due to minimal systemic absorption.

Trimester-Specific Risks:

First Trimester: No known risks.
Second Trimester: No known risks.
Third Trimester: No known risks.
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Lactation

Considered safe for use during breastfeeding. Minimal systemic absorption by the mother means negligible exposure to the infant. Avoid applying to the nipple area immediately prior to nursing to prevent direct infant ingestion.

Infant Risk: Very low risk (L1).
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Pediatric Use

Safe and commonly used in infants and children for diaper rash and minor skin irritations. No specific dose adjustments needed for age.

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Geriatric Use

Safe for use in geriatric patients. No specific dose adjustments needed. May be useful for skin folds and incontinence-associated dermatitis.

Clinical Information

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Clinical Pearls

  • Zinc oxide ointment is a cornerstone for diaper rash prevention and treatment due to its effective barrier properties.
  • Apply a thick layer to ensure adequate protection, especially at bedtime or when prolonged exposure to wetness is expected.
  • Can be used for other minor skin irritations, chafing, and as a mild sunscreen (though dedicated sunscreens are more effective for broad-spectrum UV protection).
  • Ensure the skin is clean and dry before application for optimal effectiveness.
  • While generally safe, discontinue use and consult a healthcare provider if the rash worsens or shows signs of infection.
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Alternative Therapies

  • Petrolatum (Vaseline)
  • Lanolin
  • Dimethicone-based barrier creams
  • Calamine lotion (for drying oozing lesions)
  • Low-potency topical corticosteroids (e.g., hydrocortisone 0.5-1% for inflammatory rashes, under medical supervision)
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Cost & Coverage

Average Cost: $5 - $15 per 28.4gm tube
Generic Available: Yes
Insurance Coverage: Often not covered by prescription insurance; may be eligible for FSA/HSA.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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.