Active Ingredient
Miconazole Nitrate 2% (100 mg in each applicator)
Miconazole Nitrate
FDA Label NDC 21695-854
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Miconazole Nitrate (NDC 21695-854). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, uses, warnings, other information, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Vaginal antifungal
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a
Poison Control Center right away.
Uses
. treats repeat vaginal yeast infections
. relieves external itching and irritation due to a repeat vaginal yeast infection
Warnings
For vaginal use only
Ask a doctor before use if you have
. never had a vaginal yeast infection diagnosed by a doctor
. 1 or more of the following:
abdominal pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge
. vaginal yeast infections often (such as once a month or 3 in 6 months)
. been exposed to the human immunodeficiency virus (HIV) that causes AIDS
Ask a doctor or pharmacist before use if you are taking the prescription
blood thinning medication warfarin, because bleeding or bruising may occur.
When using this product
. do not use tampons, douches, spermicides, or other vaginal products
. do not have vaginal intercourse
. condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)
Stop use and ask a doctor if
. symptoms do not get better in 3 days
. symptoms last more than 7 days
. you get abdominal pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge, or rash
If pregnant or breast-feeding, ask a health professional before use.
Other Information
. do not purchase if printed "Safety Sealed" carton
overwrap is broken or missing
. do not use if seal over tube opening has been punctured or cannot be seen
. store at room temperature 15°-30°C (59°-86°F), avoid heat over 30°C or 86°F.
Directions
. before using this product read the enclosed consumer
information leaflet for complete instructions
. adults and children 12 years of age and over:
. applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
. external cream: squeeze a small amount of cream onto your fingertip.
Gently apply the cream onto the itchy, irritated skin outside the
vagina. Use daily for up to 7 days as needed
. children under 12 years of age: ask a doctor
Inactive Ingredients
benzoic acid, BHA, mineral oil, peglicol 5 oleate,
pegoxol 7 stearate, purified water
Package/Label Principal Display Panel
Miconazole Nitrate 2% (6791d4f2 C485 4daf 82c7 0cafa9a7a17d 01)
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