Label: MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS- miconazole nitrate kit
- NDC Code(s): 63736-023-15
- Packager: Insight Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated July 9, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
For vaginal use only
Ask a doctor before use if you have
-
vaginal itching and discomfort for the first time
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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 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 disease (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
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vaginal itching and discomfort for the first time
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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:
▪ applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after use.
▪ external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the 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
- before using this product read the enclosed consumer information leaflet for complete directions and information
- Other information
- Inactive ingredients
- Questions?
-
PRINCIPAL DISPLAY PANEL - Kit Carton
MONISTAT® 7
C O M B I N A T I O N P A C K
Miconazole Nitrate Vaginal Cream (2%) and Miconazole Nitrate Vaginal Cream (2%)
VAGINAL ANTIFUNGAL
• CURES most vaginal YEAST INFECTIONS• Relieves associated external itching and irritation
VAGINAL CREAM
with 7 Disposable Applicators
plus External Cream for Itch Relief
Net Wt. 1.59 oz (45g)
+ 0.32 oz (9g) Tube
7-DAY
TREATMENT
COMBINATION PACK
Cream
7 Disposable Applicators plus External Cream for Itch Relief
TAMPER-EVIDENT UNIT
DO NOT USE IF SEAL OVER TYPE
HAS BEEN PUNCTURED.
If you have any
questions or
comments, please call
1-877-MONISTAT
(1-877-666-4782)
Dist. by Insight Pharmaceuticals LLC. Tarrytown, NY 10591
A Prestige Consumer Healthcare company
©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
All rights reserved, MNUS1107COMBINATION PACK
Miconazole Nitrate Vaginal Cream (2%) and Miconazole Nitrate Cream (2%)
VAGINAL ANTIFUNGALVAGINAL CREAM
with 7 Disposable Applicators Net Wt. 1.59 oz. (45g)
plus External Cream for Itch Relief + 0.32 oz. (9g) tube
-
INGREDIENTS AND APPEARANCE
MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS
miconazole nitrate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-023 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-023-15 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 04/23/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 7 TUBE, WITH APPLICATOR 35 g Part 2 1 TUBE 9 g Part 1 of 2 MICONAZOLE NITRATE
miconazole nitrate creamProduct Information 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) Cetyl Alcohol (UNII: 936JST6JCN) Isopropyl Myristate (UNII: 0RE8K4LNJS) Polysorbate 60 (UNII: CAL22UVI4M) Potassium Hydroxide (UNII: WZH3C48M4T) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Stearyl Alcohol (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 5 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/26/1993 Part 2 of 2 MICONAZOLE NITRATE
miconazole nitrate creamProduct Information 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) Cetyl Alcohol (UNII: 936JST6JCN) Isopropyl Myristate (UNII: 0RE8K4LNJS) Polysorbate 60 (UNII: CAL22UVI4M) Potassium Hydroxide (UNII: WZH3C48M4T) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Stearyl Alcohol (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 9 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/26/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/23/2020 Labeler - Insight Pharmaceuticals LLC (055665422) Registrant - Apex International Mfg., Inc. (079110793) Establishment Name Address ID/FEI Business Operations Apex International Mfg., Inc. 079110793 manufacture(63736-023)