Label: PROSTAT PROTECTIVE COATING BANDAGE FIRST AID- benzethonium chloride and benzocaine aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 58228-0102-3 - Packager: ProStat First Aid
- This is a repackaged label.
- Source NDC Code(s): 52982-105
- 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 February 24, 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
- Other information
- Inactive ingredients
- Principal Display
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INGREDIENTS AND APPEARANCE
PROSTAT PROTECTIVE COATING BANDAGE FIRST AID
benzethonium chloride and benzocaine aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58228-0102(NDC:52982-105) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 170 mg in 85 g BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 2720 mg in 85 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ISOBUTANE (UNII: BXR49TP611) BUTANE (UNII: 6LV4FOR43R) PROPANE (UNII: T75W9911L6) COPOVIDONE K25-31 (UNII: D9C330MD8B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58228-0102-3 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 part333A 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(58228-0102)