
USFDA APPLICATION NUMBER - 19579 / DOSAGE - CREAM;VAGINAL - 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength | 
|---|---|---|
| TERCONAZOLE(UNII: 0KJ2VE664U) (TERCONAZOLE - UNII:0KJ2VE664U)  | TERCONAZOLE | 4mg in 1 | 8mg in 1 | 80mg | 
Inactive Ingredients
| Ingredient Name | Actavis Pharma, Inc  | Janssen Pharmaceuticals, Inc.  | Ortho-McNeil-Janssen Pharmaceutical  | 
					
|---|---|---|---|
| BUTYLATED HYDROXYANISOLE(REK4960K2U) | |||
| CETYL ALCOHOL(936JST6JCN) | |||
| COCONUT OIL(Q9L0O73W7L) | |||
| ISOPROPYL MYRISTATE(0RE8K4LNJS) | |||
| PALM KERNEL OIL(B0S90M0233) | |||
| POLYSORBATE 60(CAL22UVI4M) | |||
| POLYSORBATE 80(6OZP39ZG8H) | |||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||
| STEARYL ALCOHOL(2KR89I4H1Y) | |||
| WATER(059QF0KO0R) |