BLOOD CLOTTING FIRST AID- benzethonium chloride and lidocaine aerosol, spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)
Available from:
Unifirst First Aid Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical antiseptic Topical anesthetic - for help in control of superficial bleeding - for temporary relief of pain and to help protect against infection in minor cuts, scrapes, and burns - in or near eyes or other mucus membranes - - in case of serious burns - - in case of deep or puncture wounds - - for a prolonged period of time - - on a large portion of the body - - on raw surfaces - - on blistered areas - condition worsens or symptoms persist for more than 7 days - - condition clears up and recurs within a few days - - redness, swelling, or irritation occurs
Authorization status:
OTC monograph not final
Authorization number:
47682-226-17

BLOOD CLOTTING FIRST AID- benzethonium chloride and lidocaine aerosol, spray

Unifirst First Aid Corporation

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.

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Medi-First Blood Clotting Spray

Drug Facts

Active Ingredients

Benzethonium Chloride 0.2% w/w

Lidocaine 4% w/w

Purpose

Topical antiseptic

Topical anesthetic

Uses

for help in control of superficial bleeding

for temporary relief of pain and to help protect against infection in minor cuts, scrapes, and burns

Warnings

For external use only

Flammable

keep away from fire or flame

contents under pressure

do not puncture or incinerate container

Do not use

in or near eyes or other mucus membranes

in case of serious burns

in case of deep or puncture wounds

for a prolonged period of time

on a large portion of the body

on raw surfaces

on blistered areas

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days

condition clears up and recurs within a few days

redness, swelling, or irritation occurs

Keep out of reach of children.

.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

clean the affected area

shake can well before using

hold 6-8 inches from surface

spray until area is covered and superficial bleeding is stopped

scab-like cover will gradually disappear or may be removed with soap and water

for adult institutional use only

not intended for use on children under 12 years of age

Other information

avoid inhaling

use only as directed

intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal

Store at room temperature 59-86°F (15-30°C)

do not expose to temperatures above 120°F

Inactive ingredients

isobutane, isopropyl myristate, karaya, n-butane, propane, silica, sorbitan monooloate, talc, tragacanth.

Questions or comments?

1-800-634-7680

Medi-First Blood Clotting Spray Label

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)

BLOOD CLOTTING FIRST AID

benzethonium chloride and lidocaine aerosol, spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:476 8 2-226 (NDC:529 8 2-10 6 )

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

340 0 mg

in 8 5 g

BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744) (BENZETHONIUM -

UNII:1VU15B70 BP)

BENZETHONIUM

CHLORIDE

170 mg in 8 5 g

Inactive Ingredients

Ingredient Name

Stre ng th

ISO BUTANE (UNII: BXR49 TP6 11)

Unifirst First Aid Corporation

ISO BUTANE (UNII: BXR49 TP6 11)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

KARAYA GUM (UNII: 73W9 IQY50 Q)

BUTANE (UNII: 6 LV4FOR43R)

PRO PANE (UNII: T75W9 9 11L6 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO RBITAN MO NO O LEATE (UNII: 0 6 XEA2VD56 )

TALC (UNII: 7SEV7J4R1U)

TRAGACANTH (UNII: 29 44357O2O)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:476 8 2-226 -

8 5 g in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/0 5/20 13

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 4/0 5/20 13

Labeler -

Unifirst First Aid Corporation (832947092)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dixo n Investments, Inc.

1153158 22

manufacture(476 8 2-226 ) , relabel(476 8 2-226 ) , repack(476 8 2-226 )

Revised: 6/2020

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