ANTISEPTIC- benzalkonium chloride, benzocaine liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y), benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5)

Available from:

Afassco Inc.

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

Summary of Product characteristics

ANTISEPTIC- BENZALKONIUM CHLORIDE, BENZOCAINE LIQUID
AFASSCO INC.
_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._
----------
ANTISEPTIC CUT CLEANER
Drug Facts
ACTIVE INGREDIENTS
Benzalkonium Chloride 0.1%
Benzocaine 5.0%
PURPOSE
First Aid Antiseptic
Topical Pain Relief
USES
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 area and spray 1 to 3 times daily
tear open packet, unfold towelette and apply on 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
PRINCIPAL DISPLAY PANEL –PACKET LABEL
Afassco
The First Choice
in First Aid
TRIPLE ACTION
CUT CLEANER
ANTISEPTIC
WIPE
1 premoistened towelette
Manufactured for
Afassco
Minden, NV 89423 800-441-6774
res
ANTISEPTIC
benzalkonium chloride, benzocaine liquid
PRODUCT INFORMATION
Afassco Inc.
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:51532-5301
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (benzalkonium -
UNII:7N6JUD5X6Y)
benzalkonium
chloride
1.0 mg in 1 mL
BENZOCAINE (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5)
benzocaine
50.0 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING E