Label: 7 DAY VAGINAL- miconazole nitrate cream
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 12, 2011
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- Active Ingredient
- 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
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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
- Inactive ingredients
PRINCIPAL DISPLAY PANEL
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)
DUBLIN, OH 43017
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.
INGREDIENTS AND APPEARANCE
7 DAY VAGINAL
miconazole nitrate cream
Product 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)