ANTISEPTIC- benzalkonium chloride, benzocaine spray

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Benzalkonium Chloride 0.1%, Benzocaine 5.0%

Disponible desde:

Safetec of America, Inc.

Vía de administración:

TOPICAL

tipo de receta:

OTC DRUG

indicaciones terapéuticas:

First Aid Antiseptic Topical Pain Relief First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

Estado de Autorización:

OTC monograph not final

Ficha técnica

ANTISEPTIC- BENZALKONIUM CHLORIDE, BENZOCAINE SPRAY
SAFETEC OF AMERICA, INC.
----------
61010-5300, CUT AND SCRAPE ANTISEPTIC
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 IFcondition persists or gets worse
DIRECTIONS
clean affected and spray 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 – BOTTLE LABEL
NDC 61010-5300-0
Safetec
Cut & Scrape
Antiseptic Spray
For Temporary Pain
Relief and to Help
Prevent Infection in
Minor Cuts, Scrapes
and Abrasions.
2 fl. oz. (59.1ml)
Reorder no. 53000
ANTISEPTIC
benzalkonium chloride, benzocaine spray
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:61010-5300
Safetec of America, Inc.
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
1 mg in 1 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)
BENZ OCAINE
50 mg
in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:61010-
5300-2
90 g in 1 BOTTLE, SPRAY; Type 0: Not a
Combination Product
02/15/2012
2
NDC:61010-
5300-0
60 g in 1 BOTTLE, SPRAY; Type 0: Not a
Combination Product
02/15/2012
MARKETING INFORMATION
MARKETING
CATEGORY
APPLI