NDC | 24909-201-28 |
Set ID | 72d74cbc-4abf-492a-9b60-3793c33b16c4 |
Category | HUMAN OTC DRUG LABEL |
Packager | Aidance Skincare & Topical Solutions, LLC |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Active Ingredient
- Purpose
- Use
- Warnings
-
ASK DOCTOR
Ask 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.
- WHEN USING
- STOP USE
- Directions
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
- Other Information
- Inactive Ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 28g Carton
-
INGREDIENTS AND APPEARANCE
FEMMESIL CREME MAXIMUM STRENGTH
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2.0 g in 100 g Inactive Ingredients Ingredient Name Strength BENTONITE (UNII: A3N5ZCN45C) JOJOBA OIL (UNII: 724GKU717M) PEPPERMINT OIL (UNII: AV092KU4JH) SILVER OXIDE (UNII: 897WUN6G6T) TEA TREE OIL (UNII: VIF565UC2G) WATER (UNII: 059QF0KO0R) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-201-28 1 in 1 CARTON 1 28 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 09/07/2012 Labeler - Aidance Skincare & Topical Solutions, LLC (018950611) Establishment Name Address ID/FEI Business Operations Aidance Skincare & Topical Solutions, LLC 018950611 manufacture(24909-201) , label(24909-201)