MICONAZOLE NITRATE cream

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-854(NDC:0713-0252)
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-854-45	45 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2008

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK