Miconazole and zinc oxide topical over the counter

Dosing & Uses

AdultPediatric

Not indicated

Dosage Forms & Strengths

miconazole/petrolatum/zinc oxide

topical ointment

  • 0.25%/81.35%/15%

Diaper Dermatitis

Indicated as adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis

<4 weeks: Safety and efficacy not established

≥4 weeks: Apply thin layer to diaper area at each diaper change for 7 days

Administration

Before applying, gently cleanse the skin with lukewarm water and pat dry with a soft towel

Avoid using any scented soaps, shampoos, or lotions on the diaper area

Continue treatment for the full 7 days, even if there is improvement; do not apply longer than 7 days, if symptoms have not improved by day 7, contact healthcare provider

Gently apply a thin layer of ointment to the diaper area with the fingertips; do not rub into the skin as this may cause additional irritation

Thoroughly wash hands after application

Adverse Effects

Postmarketing Reports

Skin: Burning sensation, condition aggravated, inflammation, pruritus, rash, skin exfoliation

Warnings

Contraindications

None

Cautions

Not a substitute for frequent diaper changes

If irritation occurs or worsens, discontinue use and contact healthcare provider

Safety and efficacy not demonstrated in immunocompromised patients or incontinent adults

Should not be used to prevent diaper dermatitis (ie, adult institutional setting); preventive use may result in drug resistance

Pregnancy & Lactation

Pregnancy

There are no available data on ointment use in pregnant women to inform a drug-associated risk for adverse developmental outcomes

Animal data

  • In animal reproduction studies, prolonged gestation, increased number of resorptions, and decreased numbers of live young were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits; no comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration

Lactation

There is no available information on presence of miconazole in human milk, or effects on breastfed child, or on milk production

Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Pharmacology

Mechanism of Action

Miconazole: Antifungal agent; elicits in vitro activity against Candida albicans by inhibiting ergosterol biosynthesis in the cell membrane; accumulation of ergosterol precursors and toxic peroxides results in cytolysis of the cell

Absorption

Negligible

Images

BRANDFORM.UNIT PRICEPILL IMAGE
miconazole nitrate-zinc oxide-petrolatum topical

-

0.25-15-81.35 % ointment
Miconazole and zinc oxide topical over the counter
Vusion topical

-

0.25-15-81.35 % ointment
Miconazole and zinc oxide topical over the counter
Vusion topical

-

0.25-15-81.35 % ointment
Miconazole and zinc oxide topical over the counter

Copyright © 2010 First DataBank, Inc.

Patient Handout

A Patient Handout is not currently available for this monograph.

Formulary

FormularyPatient Discounts

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View explanations for tiers and restrictions

TierDescription
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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CodeDefinition
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

What is miconazole and zinc oxide topical?

What is miconazole and zinc oxide topical? Miconazole and zinc oxide topical (for the skin) is a combination antifungal medicine that fights infections caused by fungus. The ointment form is used to treat diaper rash with yeast infection (candidiasis) in children and babies who are at least 4 weeks old.

Can you mix miconazole and zinc oxide?

Miconazole, zinc oxide, and white petrolatum combination is used to treat diaper rash (dermatitis) in infants 4 weeks of age and older with a normal immune system who also have a yeast infection (candidiasis).

Is miconazole nitrate available over

Miconazole (Monistat) is available over-the-counter, but is usually more expensive than fluconazole and can cause or worsen things like burning, itching, and irritation.

Can zinc oxide treat fungal infection?

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.