MICONAZOLE 3- miconazole nitrate cream

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M)
Available from:
TARGET Corporation
Administration route:
VAGINAL
Prescription type:
OTC DRUG
Therapeutic indications:
Vaginal antifungal - treats vaginal yeast infections
Authorization status:
Abbreviated New Drug Application
Authorization number:
11673-391-06

Read the complete document

MICONAZOLE 3- miconazole nitrate cream

TARGET Corporation

----------

Miconazole 3

Drug Facts

Active ingredient

Miconazole nitrate USP 4%

Purpos e

Vaginal antifungal

Us e

treats vaginal yeast infections

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 (1-

800-222-1222) 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:

insert 1 applicatorful into the vagina at bedtime for 3 nights in a row.

Throw applicator away after use.

children under 12 years of age: ask a doctor

Other information

do not use if seal over tube opening has been punctured

do not purchase if carton is open

store at 20° to 25°C (68° to 77°F)

see end flaps of carton and end of tube for lot number and expiration date

Inactive ingredients

cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene

glycol, purified water, sorbitan monostearate and stearyl alcohol.

Ques tions ?

call 1-866-923-4914

Dist. by Target Corp., Mpls., MN 55403

PRINCIPAL DISPLAY PANEL - 25 g Tube Carton

NDC 11673-391-06

Compare to the active ingredient in Monistat

up&up

3-day treatment

miconazole 3

miconazole nitrate vaginal cream USP (4%)

vaginal antifungal

cures most vaginal yeast infections

ONE 0.9 OZ (25 g) TUBE OF 3 DAY VAGINAL CREAM AND THREE DISPOSABLE

APPLICATORS

MICONAZOLE 3

miconazole nitrate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:116 73-39 1

Route of Administration

VAGINAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Mico na zo le Nitra te (UNII: VW4H1CYW1K) (Mico nazo le - UNII:7NNO0 D7S5M)

Mico nazo le Nitrate

40 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

cetyl a lco ho l (UNII: 9 36 JST6 JCN)

iso pro pyl myrista te (UNII: 0 RE8 K4LNJS)

po lyso rba te 6 0 (UNII: CAL22UVI4M)

po lyso rba te 8 0 (UNII: 6 OZP39 ZG8 H)

po ta ssium hydro xide (UNII: WZH3C48 M4T)

pro pylene g lyco l (UNII: 6 DC9 Q16 7V3)

wa ter (UNII: 0 59 QF0 KO0 R)

so rbita n mo no stea ra te (UNII: NVZ4I0 H58 X)

stea ryl a lco ho l (UNII: 2KR8 9 I4H1Y)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:116 73-39 1-

1 in 1 CARTON

10 /14/20 20

1

25 g in 1 TUBE, WITH APPLICATOR; Type 0 : No t a Co mbinatio n

Pro duc t

TARGET Corporation

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 773

0 3/0 2/20 0 5

Labeler -

T ARGET Corporation (006961700)

Revised: 10/2020

Similar products

Search alerts related to this product

View documents history

Share this information