NDC | 24909-203-25, 24909-203-50 |
Set ID | efddad82-9dc7-4cd9-b33c-7e85f30d992e |
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 - 50g Tube
-
INGREDIENTS AND APPEARANCE
FEMMESIL
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1.0 g in 100 g Inactive Ingredients Ingredient Name Strength COTTONSEED OIL (UNII: H3E878020N) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) JOJOBA OIL (UNII: 724GKU717M) PEPPERMINT OIL (UNII: AV092KU4JH) SHEA BUTTER (UNII: K49155WL9Y) SILVER OXIDE (UNII: 897WUN6G6T) SORBIC ACID (UNII: X045WJ989B) STEARIC ACID (UNII: 4ELV7Z65AP) TEA TREE OIL (UNII: VIF565UC2G) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-203-25 1 in 1 CARTON 11/30/2014 1 25 g in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:24909-203-50 50 g in 1 TUBE; Type 0: Not a Combination Product 12/31/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 11/30/2014 Labeler - Aidance Skincare & Topical Solutions, LLC (018950611) Establishment Name Address ID/FEI Business Operations Aidance Skincare & Topical Solutions, LLC 018950611 manufacture(24909-203) , label(24909-203)