Label: AEROWOUND BLOOD CLOTTING FIRST AID- benzethonium chloride and lidocaine aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 55305-114-10 - Packager: Aero Healthcare, LLC.
- Category: HUMAN OTC DRUG LABEL
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 August 20, 2014
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- Stop use and ask doctor if
- Keep out of reach of children.
- Directions
- Inactive Ingredients
- Principal Display
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INGREDIENTS AND APPEARANCE
AEROWOUND BLOOD CLOTTING FIRST AID
benzethonium chloride and lidocaine aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55305-114(NDC:52982-106) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 756.5 mg in 85 g BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 76.5 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) 3-(TRIETHOXYSILYL)PROPYLAMINE (UNII: L8S6UBW552) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TALC (UNII: 7SEV7J4R1U) TRAGACANTH (UNII: 2944357O2O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55305-114-10 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 08/20/2014 Labeler - Aero Healthcare, LLC. (008186174) Registrant - Dixon Investments, Inc. (115315822) Establishment Name Address ID/FEI Business Operations Dixon Investments, Inc. 115315822 manufacture(55305-114)