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USFDA APPLICATION NUMBER - 19941 / DOSAGE - CREAM;TOPICAL - 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| LIDOCAINE(UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) | LIDOCAINE | 25mg in 1 | 25mg in 1 |
| PRILOCAINE(UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R) | PRILOCAINE | 25mg in 1 | 25mg in 1 |
Inactive Ingredients
| Ingredient Name | PureTek Corporation | Fortus Pharma, LLC | NuCare Pharmaceuticals,Inc. | Akorn, Inc. | Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) | Preferred Pharmaceuticals Inc. | Welgo, Llc | Allergan, Inc. | APP Pharmaceuticals, LLC |
|---|---|---|---|---|---|---|---|---|---|
| CALCIUM ACETATE(Y882YXF34X) | |||||||||
| CARBOMER 934(Z135WT9208) | |||||||||
| CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)(Z135WT9208) | |||||||||
| CETOSTEARYL ALCOHOL(2DMT128M1S) | |||||||||
| GLYCERIN(PDC6A3C0OX) | |||||||||
| METHYLPARABEN(A2I8C7HI9T) | |||||||||
| MINERAL OIL(T5L8T28FGP) | |||||||||
| PEG-54 HYDROGENATED CASTOR OIL(0WZF1506N9) | |||||||||
| PEG-55 HYDROGENATED CASTOR OIL(0WZF1506N9) | |||||||||
| PETROLATUM(4T6H12BN9U) | |||||||||
| POLYOXYL 20 CETOSTEARYL ETHER(YRC528SWUY) | |||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||
| PROPYLPARABEN(Z8IX2SC1OH) | |||||||||
| SODIUM HYDROXIDE(55X04QC32I) | |||||||||
| SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(KH7I04HPUU) | |||||||||
| water(059QF0KO0R) |
