Description
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).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Ointment
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of miconazole, zinc oxide, and white petrolatum combination in infants younger than 4 weeks of age and in very-low-birth-weight infants (less than 1500 grams). Safety and efficacy have not been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of miconazole, zinc oxide, and white petrolatum combination in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Etonogestrel
- Warfarin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Ethinyl Estradiol
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
This medicine is for use only on your child's skin. Do not get any of it into your child's eyes, nose, mouth, or vagina. Rinse it off right away if it does get on these areas.
To use this medicine:
- Wash your hands with soap and water before and after you apply this medicine onto your child's diaper area.
- Change wet and soiled diapers right away. Clean the diaper area with lukewarm water and pat dry with a soft towel.
- Apply a thin layer of this medicine on your child's diaper area at each diaper change. Do not rub into your child's skin.
Keep using this medicine for the full 7 days, even if your child feels better after the first few doses. Your child's infection may not clear up if you stop the medicine too soon.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For topical dosage form (ointment):
- For diaper rash with yeast infection:
- Infants 4 weeks of age and older and weighing 1500 grams (g) or more—Gently apply a thin layer to the diaper area with each diaper change for 7 days.
- Infants younger than 4 weeks of age and weighing less than 1500 g—Use and dose must be determined by your doctor.
- For diaper rash with yeast infection:
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
If the rash gets worse or does not get better after 7 days, call your doctor right away.
Do not use this medicine to prevent diaper rash.
Clean the diaper area and change your child’s diaper often to prevent worsening of skin irritation.
Avoid using scented soaps, shampoos, or lotions in the diaper area during treatment with this medicine.
Each antifungal medicine is made to treat a certain kind of infection. Use only the medicine your doctor has prescribed. You should not use an over-the-counter product in place of what your doctor has told you to use.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Blistering, burning, crusting, dryness, flaking, itching, scaling, or severe redness, soreness, or swelling of the skin
- falling off of skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20443980
