NDC | 37205-590-29 |
Set ID | 1b95ccd9-ce8d-50cb-2db1-05ad9924811a |
Category | HUMAN OTC DRUG LABEL |
Packager | Cardinal Health |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Active Ingredient
- Purpose
- Uses
-
treats repeat vaginal yeast infections
-
relieves external itching and irritation due to a repeat vaginal yeast infection
-
- Warnings
- Do not use
- 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 medication warfarin, because bleeding or bruising may occur.
Close - 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 a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
-
- If pregnant or breast-feeding,
- Keep out of reach of children.
- 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
-
- Other information
-
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.
-
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
NDC 37205-590-29
LEADER®
7 DAY VAGINAL CREAM
Miconazole NitrateVAGINAL CREAM 2% • VAGINAL ANTIFUNGAL
Cures most vaginal yeast infections.
Relieves external vulvar itching and irritation associated with a yeast infection
Compare to Monistat® 7 active ingredient*
NET WT 1.59 OZ (45 g)
SATISFACTION GUARANTEED
DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OH 43017
CIN 1362490
www.myleader.com
1-800-200-6313
All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
*This product is not manufactured or distributed by Johnson & Johnson, distributor or manufacturer of MONISTAT® 7. MONISTAT® 7 is a registered trademark of Johnson & Johnson.
10-25237LR2 - INGREDIENTS AND APPEARANCE
7 DAY VAGINAL
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-590 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate 2 g in 100 g Inactive Ingredients Ingredient Name Strength Benzoic Acid (UNII: 8SKN0B0MIM) Butylated Hydroxyanisole (UNII: REK4960K2U) Mineral Oil (UNII: T5L8T28FGP) Peg-5 Oleate (UNII: 0240V77G50) Pegoxol 7 Stearate (UNII: 3EW5AXE5X5) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-590-29 45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/16/2009 Labeler - Cardinal Health (097537435) Registrant - G & W Laboratories, Inc. (001271188) Establishment Name Address ID/FEI Business Operations G & W Laboratories, Inc. 001271188 MANUFACTURE(37205-590)