FIRST AID ANTISEPTIC- benzalkonium chloride, benzocaine spray

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

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Active ingredient:
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y), benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5)
Available from:
First Aid Only
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
First Aid Antiseptic Topical Pain Relief First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns
Authorization status:
OTC monograph not final
Authorization number:
62985-5081-1

FIRST AID ANTISEPTIC- benzalkonium chloride, benzocaine spray

First Aid Only

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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Drug Facts

Active Ingredients

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Purpos e

First Aid Antiseptic

Topical Pain Relief

Us es

First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

Warnings

For external use only. Flammable keep away from fire or flame.

Do not use

near eyes or mucous membranes

on deep or puncture wounds, animal bites, or serious burns

over large areas of the body

more than one week unless directed by a doctor

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right

away.

Stop use and ask doctor if condition persists or gets worse

Directions

clean affected and spray

spray over the area 1 to 3 times daily

may be covered with a sterile bandage

children under 2 ask a doctor.

Inactive ingredients

isopropyl alcohol, purified water

First Aid Antiseptic

Temporary pain relief. Helps prevent infection in minor cuts, scrapes and abrasions.

M5081

3 fl. oz (88.7 ml.)

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FIRST AID ONLY

Distributed by First Aid Only, Inc

Vancouver, WA 96882 USA

FIRST AID ANTISEPTIC

benzalkonium chloride, benzocaine spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 29 8 5-50 8 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

benza lko nium chlo ride (UNII: F5UM2KM3W7) (benzalko nium - UNII:7N6 JUD5X6 Y)

benzalko nium chlo ride

0 .9 6 g in 1 L

benzo ca ine (UNII: U3RSY48 JW5) (benzo caine - UNII:U3RSY48 JW5)

be nz o c a ine

58 .5 g in 1 L

First Aid Only

Inactive Ingredients

Ingredient Name

Stre ng th

iso pro pyl a lco ho l (UNII: ND2M416 30 2)

wa ter (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 29 8 5-50 8 1-1

0 .0 8 8 7 L in 1 BOTTLE, SPRAY

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 rt333A

0 8 /13/20 14

Labeler -

First Aid Only (196551634)

Registrant -

Safetec of America, Inc. (874965262)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Safetec o f America, Inc.

8 749 6 526 2

MANUFACTURE(6 29 8 5-50 8 1)

Revised: 8/2014

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