NDC | 58228-0103-3 |
Set ID | 09b1372c-a5a3-4d89-9b8e-4523f6a0341f |
Category | HUMAN OTC DRUG LABEL |
Packager | ProStat First Aid |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- Stop use and ask a doctor if
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- Directions
- Inactive ingredients
- Principal Display
-
INGREDIENTS AND APPEARANCE
PROSTAT BLOOD CLOTTING FIRST AID
benzethonium chloride and lidocaine aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58228-0103(NDC:52982-106) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 3400 mg in 85 g BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 170 mg in 85 g Inactive Ingredients Ingredient Name Strength ISOBUTANE (UNII: BXR49TP611) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) KARAYA GUM (UNII: 73W9IQY50Q) BUTANE (UNII: 6LV4FOR43R) PROPANE (UNII: T75W9911L6) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TALC (UNII: 7SEV7J4R1U) TRAGACANTH (UNII: 2944357O2O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58228-0103-3 85 g in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/18/2014 Labeler - ProStat First Aid (061263699) Registrant - Dixon Investments, Inc. (115315822) Establishment Name Address ID/FEI Business Operations Dixon Investments, Inc. 115315822 manufacture(58228-0103)