NDC Code(s) : 47682-226-17
Packager : Unifirst First Aid Corporation

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Blood Clotting First Aidbenzethonium chloride and lidocaine AEROSOL, SPRAY
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-226
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE(UNII: 98PI200987)
(LIDOCAINE - UNII:98PI200987)
LIDOCAINE3400 mg in 85 g
BENZETHONIUM CHLORIDE(UNII: PH41D05744)
(BENZETHONIUM - UNII:1VU15B70BP)
BENZETHONIUM CHLORIDE170 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
1NDC:47682-226-1785 g in 1 BOTTLE, SPRAY Type 0: Not a Combination Product04/05/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M003 04/05/2013

LABELER - Unifirst First Aid Corporation(832947092)

Establishment
Name Address ID/FEI Business Operations
Dixon Investments, Inc. 115315822 manufacture(47682-226)

PRINCIPAL DISPLAY PANEL

Medi-First® Blood Clotting Spray

  • Aids in control of bleeding
  • Temporarily relieves pain of minor cuts, burns and scrapes
  • Helps prevent infection
  • Coantains no fluorocarbons
  • Aerosol
  • Warning: FLAMMABLE
  • Contents under pressure, read Back Panel Carefully
  • Net Weight 3 oz (85g)

Medi-First