United States - English - NLM (National Library of Medicine)
MICONAZOLE 3- miconazole nitrate cream
Miconazole nitrate USP 4%
treats vaginal yeast infections
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
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
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.
before using this product read the enclosed consumer information leaflet for complete directions
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
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
cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene
glycol, purified water, sorbitan monostearate and stearyl alcohol.
Ques tions ?
Dist. by Target Corp., Mpls., MN 55403
PRINCIPAL DISPLAY PANEL - 25 g Tube Carton
Compare to the active ingredient in Monistat
miconazole nitrate vaginal cream USP (4%)
cures most vaginal yeast infections
ONE 0.9 OZ (25 g) TUBE OF 3 DAY VAGINAL CREAM AND THREE DISPOSABLE
miconazole nitrate cream
Product T ype
HUMAN OTC DRUG
Ite m Code (Source )
NDC:116 73-39 1
Route of Administration
Active Ingredient/Active Moiety
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
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)
NDC:116 73-39 1-
1 in 1 CARTON
10 /14/20 20
25 g in 1 TUBE, WITH APPLICATOR; Type 0 : No t a Co mbinatio n
Pro duc t
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
ANDA0 76 773
0 3/0 2/20 0 5
T ARGET Corporation (006961700)