Zinc Oxide 20% Ointment 60gm

Manufacturer RUGBY LABORATORIES 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 Protectant
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Pregnancy 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 creates a protective barrier on your skin. It helps to soothe and prevent skin irritation, especially from wetness, like in diaper rash, or from minor cuts and scrapes.
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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 which case you should not wash it 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 to prevent skin irritation.
Clean the affected area and allow it to dry before reapplying the medication, especially at bedtime.

Storage and Disposal

Store this medication at room temperature in a dry place, avoiding bathrooms and areas prone to moisture.
Keep all medications in a safe and secure 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

  • Cleanse the affected area gently with mild soap and water, then pat dry completely before applying the ointment.
  • For diaper rash, change wet and soiled diapers promptly.
  • Apply a thick layer of ointment to ensure good coverage and protection.
  • Wash hands thoroughly before and after applying the ointment.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply liberally as often as needed to affected area.

Condition-Specific Dosing:

diaperRash: Apply with each diaper change, especially at bedtime or any time when 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 as often as needed.
Infant: Apply liberally as often as needed, especially for diaper rash.
Child: Apply liberally as often as needed.
Adolescent: Apply liberally as often as needed.
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Dose Adjustments

Renal Impairment:

Mild: Not applicable due to minimal systemic absorption.
Moderate: Not applicable due to minimal systemic absorption.
Severe: Not applicable due to minimal systemic absorption.
Dialysis: Not applicable due to minimal systemic absorption.

Hepatic Impairment:

Mild: Not applicable due to minimal systemic absorption.
Moderate: Not applicable due to minimal systemic absorption.
Severe: Not applicable due to 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 helps to prevent irritation from moisture and friction. It also possesses 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 (minimal systemic absorption)
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, barrier formation)
PeakEffect: Immediate
DurationOfAction: Until removed or rubbed off

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Be aware of the following signs of a severe allergic reaction:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin (with or without fever)
- Wheezing
- Tightness in the chest or throat
- Difficulty 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. 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. Not all possible side effects are listed here. If you have questions or concerns about side effects, discuss them with your doctor.

Reporting Side Effects
To report side effects, you can call your doctor for medical advice or contact the FDA at 1-800-332-1088. You can also submit reports online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of the rash or irritation after several days of use.
  • Signs of skin infection (e.g., pus, fever, spreading redness, warmth, swelling).
  • Severe allergic reaction (rare, but seek immediate medical attention if you experience rash, itching/swelling, severe 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 list is not exhaustive, and it is crucial to discuss all your medications (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 in conjunction with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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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. If you or someone else swallows this medication, call a doctor or contact a poison control center right away.

If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Not applicable for topical use as systemic absorption is minimal.
  • Accidental ingestion of large quantities may cause mild gastrointestinal upset (nausea, vomiting, diarrhea).

What to Do:

For accidental ingestion, contact a poison control center immediately (e.g., 1-800-222-1222 in the US). For topical use, simply wipe off excess.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition (visual inspection)

Rationale: To assess the extent and type of irritation or rash before treatment.

Timing: Prior to first application

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Routine Monitoring

Resolution of symptoms (redness, irritation, rash)

Frequency: Daily or with each application

Target: Improvement or complete resolution of skin irritation.

Action Threshold: If symptoms worsen, persist for more than 7 days, or signs of infection develop (e.g., pus, fever), discontinue use and consult a healthcare provider.

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Symptom Monitoring

  • Reduction in redness
  • Decrease in skin irritation
  • Healing of rash
  • Absence of new skin breakdown

Special Patient Groups

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Pregnancy

Generally 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

Generally considered safe for use during lactation. Minimal systemic absorption means negligible transfer into breast milk. If applied to the breast area, ensure it is wiped off before breastfeeding to prevent infant ingestion.

Infant Risk: Low risk
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Pediatric Use

Widely used and considered safe and effective for infants and children, particularly for diaper rash and other minor skin irritations. Follow dosing instructions for liberal application.

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Geriatric Use

Safe and effective for use in the elderly, especially for incontinence-associated dermatitis and other skin protection needs. No specific dose adjustments or precautions are typically needed beyond general skin care.

Clinical Information

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Clinical Pearls

  • Apply a thick, visible layer of ointment to create an effective barrier.
  • Ensure the skin is clean and dry before application for optimal effectiveness.
  • Zinc oxide can be messy and may stain clothing; use care during application.
  • While primarily for protection, its mild astringent properties can help dry weeping or oozing skin.
  • Often used in combination with other emollients or skin protectants for comprehensive skin care.
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Alternative Therapies

  • Petrolatum (Vaseline)
  • Lanolin
  • Dimethicone-based creams
  • Calamine lotion (for drying properties)
  • Hydrocortisone cream (for inflammatory rashes, but not for routine protection)
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Cost & Coverage

Average Cost: $5 - $15 per 60gm tube
Generic Available: Yes
Insurance Coverage: Often not covered by prescription insurance plans as it is an over-the-counter (OTC) product; may be eligible for FSA/HSA reimbursement.
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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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.