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NUMBER - 19579 / DOSAGE - CREAM;VAGINAL - 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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) |
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