NDC | 21695-854-45 |
Set ID | 6791d4f2-c485-4daf-82c7-0cafa9a7a17d |
Category | HUMAN OTC DRUG LABEL |
Packager | Rebel Distributors Corp |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
-
Warnings
For vaginal use only
Ask a doctor before use if you have
. never had a vaginal yeast infection diagnosed by a doctor
. 1 or more of the following:
abdominal pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge
. vaginal yeast infections often (such as once a month or 3 in 6 months)
. 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.
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 abdominal pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge, or rash
If pregnant or breast-feeding, ask a health professional before use. - Other Information
-
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 - Inactive ingredients
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-854(NDC:0713-0252) 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) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-854-45 45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/01/2008 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK