MICONAZOLE 7- miconazole nitrate cream

Miconazole 7 by

Drug Labeling and Warnings

Miconazole 7 by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Miconazole nitrate, USP 2% (100 mg in each applicator)

Purpose

Vaginal antifungal

Uses

• treats vaginal yeast infections
• relieves external itching and irritation due to a vaginal yeast infection

Warnings

For vaginal use only

Do not use

if you have never had a vaginal yeast infection diagnosed by a doctor.

Ask a doctor before use if you have

• vaginal itching and discomfort for the first time
• lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
• vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
• 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 medicine warfarin, because bleeding or bruising may occur

When using this product

• do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
• do not have vaginal intercourse
• mild increase in vaginal burning, itching or irritation may occur
• if you do not get complete relief ask a doctor before using another product.

Stop use and ask a doctor if

• symptoms do not get better in 3 days
• symptoms last more than 7 days
• you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• before using this product read the enclosed consumer information leaflet for complete directions and information
• adults and children 12 years of age and over:
  • applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
  • use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip.  Apply to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed.
• children under 12 years of age:  ask a doctor

Other information

• to open tube use cap to puncture seal
• do not use if seal over tube opening has been punctured or is not visible
• do not purchase if carton is open
• store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F).

Inactive ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

PRINCIPAL DISPLAY PANEL

DRUG: Miconazole 7

GENERIC: Miconazole Nitrate

DOSAGE: CREAM

ADMINSTRATION: VAGINAL

NDC: 70518-1473-0

COLOR: white

PACKAGING: 45 g in 1 TUBE, WITH APPLICATOR

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

• MICONAZOLE NITRATE 20mg in 1g

INACTIVE INGREDIENT(S):

• APRICOT KERNEL OIL PEG-6 ESTERS
• BENZOIC ACID
• PEGOXOL 7 STEARATE
• BUTYLATED HYDROXYANISOLE
• MINERAL OIL
• WATER

INGREDIENTS AND APPEARANCE

MICONAZOLE 7 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-1473(NDC:0472-0730)
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)
APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-1473-0	1 in 1 CARTON	10/06/2018
1		45 g in 1 TUBE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074164	10/06/2018

Labeler - REMEDYREPACK INC. (829572556)