Label: PROSTAT BLOOD CLOTTING FIRST AID- benzethonium chloride and lidocaine aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 58228-0103-3 - Packager: ProStat First Aid
- This is a repackaged label.
- Source NDC Code(s): 52982-106
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 7, 2014
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- Official Label (Printer Friendly)
- 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
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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)