Zinc Oxide 20% Ointment 56.7gm

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; Astringent
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Pharmacologic Class
Topical barrier agent
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Pregnancy Category
Category B
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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 used to treat and prevent diaper rash and other minor skin irritations. It works by forming a protective barrier on the skin to keep out moisture and irritants.
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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 your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Gently rub the medication into the affected area.

Special Instructions for Diaper Use

If you are using this medication on a diapered area, change the diaper frequently.
Clean the affected area and allow it to dry before reapplying the medication.
Apply the medication with each diaper change, especially at bedtime.

Storage and Disposal

Store this medication at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a safe location, out of the reach of children and 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 directed by your doctor.
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Lifestyle & Tips

  • Keep the affected area clean and dry before applying the ointment.
  • Apply a thick layer to ensure adequate protection.
  • For diaper rash, change wet or soiled diapers promptly and apply the ointment with each diaper change, especially at bedtime.
  • Avoid rubbing the ointment vigorously; gently pat it onto the skin.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply liberally to affected area as often as needed, with each diaper change, or as directed by a physician.

Condition-Specific Dosing:

diaperRash: Apply with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged.
minorSkinIrritations: Apply as needed to protect and soothe irritated skin.
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Pediatric Dosing

Neonatal: Apply liberally to affected area as often as needed, with each diaper change.
Infant: Apply liberally to affected area as often as needed, with each diaper change.
Child: Apply liberally to affected area as often as needed.
Adolescent: Apply liberally to affected area as often as needed.
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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

Zinc oxide acts as a skin protectant by forming a physical barrier on the skin surface, which prevents irritation from moisture and irritants. It also has mild astringent and antiseptic properties, helping to dry and soothe irritated skin.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible systemic absorption
Tmax: Not applicable (topical action)
FoodEffect: Not applicable

Distribution:

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

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: Immediate (upon application, forms physical barrier)
PeakEffect: Not applicable (continuous barrier effect)
DurationOfAction: Until removed or worn off (requires reapplication)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention 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 help 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.

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is available to provide medical advice about side effects.
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Seek Immediate Medical Attention If You Experience:

  • Rash worsens or does not improve within 7 days.
  • Signs of skin infection (e.g., pus, oozing, fever, severe pain).
  • Allergic reaction (e.g., severe rash, itching, swelling, dizziness, trouble breathing).
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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 you have a deep wound or a puncture wound, as this may affect your treatment.

This medication can interact with other drugs and health conditions. To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems

Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. 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 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 do not exceed the recommended frequency or duration of use.

To avoid staining, take precautions to protect your clothing and fabrics when using this drug, as it may cause discoloration.

In the event of accidental ingestion, seek immediate medical attention by calling a doctor or a poison control center right away, as this medication can be harmful if swallowed.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor, as this will help you make an informed decision about its use and its potential impact on you and your baby.
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Overdose Information

Overdose Symptoms:

  • Topical overdose is unlikely to cause systemic toxicity.
  • Accidental ingestion of large amounts may cause stomach upset, nausea, vomiting, or diarrhea.

What to Do:

If accidental ingestion occurs, contact a poison control center immediately (Call 1-800-222-1222). For topical overuse, simply wipe off excess.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition (visual inspection)

Rationale: To assess baseline irritation, redness, or rash severity.

Timing: Prior to first application

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Routine Monitoring

Skin condition (visual inspection)

Frequency: Daily or with each application

Target: Reduction in redness, irritation, or rash; intact skin barrier.

Action Threshold: Worsening rash, signs of infection (e.g., pus, fever), or no improvement after 7 days.

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Symptom Monitoring

  • Worsening redness or irritation
  • Development of new rash or lesions
  • Signs of infection (e.g., pus, warmth, fever)
  • Pain or discomfort at application site

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Low risk
Second Trimester: Low risk
Third Trimester: Low risk
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Lactation

Considered safe for use during lactation. Minimal systemic absorption by the mother means negligible exposure to the infant. Avoid applying to the nipple area if breastfeeding.

Infant Risk: Low risk
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Pediatric Use

Commonly and safely used in infants and children for diaper rash and minor skin irritations. Follow dosing instructions for age.

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Geriatric Use

No specific dosage adjustments or precautions needed. Safe for use in the elderly for skin protection.

Clinical Information

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Clinical Pearls

  • Ensure the skin is clean and dry before applying zinc oxide ointment to maximize its effectiveness.
  • Apply a thick, visible layer to create an effective barrier, especially for diaper rash.
  • Zinc oxide can be difficult to remove from clothing; use caution during application.
  • While primarily for protection, its mild astringent properties can help dry weeping skin lesions.
  • Often used in combination with other ingredients (e.g., petrolatum, lanolin) in commercial products to enhance barrier properties.
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Alternative Therapies

  • Petrolatum (Vaseline)
  • Lanolin
  • Dimethicone-based barrier creams
  • Calamine lotion (for drying/soothing)
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Cost & Coverage

Average Cost: $5 - $20 per 56.7gm tube
Generic Available: Yes
Insurance Coverage: Generally not covered by prescription drug plans; may be eligible for FSA/HSA.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.