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Miconazole Nitrate by Rebel Distributors Corp

Medically reviewed on Feb 19, 2018

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Rebel Distributors Corp
NDC Code: 21695-854

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Miconazole Nitrate 2% Drug Facts

Active ingredient

Miconazole Nitrate 2% (100 mg in each applicator)

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 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-854(NDC:0713-0252)
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
MINERAL OIL 
WATER 
Packaging
#Item CodePackage Description
1NDC:21695-854-4545 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2008
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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