BENZALKONIUM CHLORIDE ANTISEPTIC- benzalkonium chloride swab

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

MAH:

NANTONG STRIP MEDICAL SUPPLY CO.,LTD.

administration_route:

TOPICAL

prescription_type:

OTC DRUG

authorization_status:

OTC monograph final

SPC

BENZALKONIUM CHLORIDE ANTISEPTIC - BENZALKONIUM CHLORIDE SWAB
NANTONG STRIP MEDICAL SUPPLY CO.,LTD.
_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._
----------
DRUG FACT
ACTIVE INGREDIENTS
Benzalkonium Chloride 0.4%
PURPOS E
Antiseptic
US E
Prevent infection in minor scrapes
WARNINGS
For external use only
Flammable,keep away for fire or flame
Do not use:
* In large quantities
* over large areas of the body
* in eyes
* over raw or blistered areas
Stop use and ask a doctor if conditions worsen or persist for more
than 7 days or clear up and occur
again within a few days.
Keep out of reach of children.if swallowed get medical help or contact
Poison control Center right
away.
DIRECTIONS
Adults and Children 2 year and older; Apply to cleaned affected area
not more than 3 times daily.
Children under 2 years of age ; Consult a doctor
INACTIVE INGREDIENT
Purified Water
BENZALKONIUM CHLORIDE ANTISEPTIC
benzalkonium chloride swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:356 17-39 3
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6 JUD5X6 Y)
BENZALKONIUM
CHLORIDE
0 .0 0 4 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:356 17-39 3-0 1
1 in 1 PACKET
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt348
0 5/20 /20 10
NANTONG STRIP MEDICAL SUPPLY CO.,LTD.
LABELER -
NANT ONG ST RIP MEDICAL SUPPLY CO.,LT D. (546585519)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
NANTONG STRIP MEDICAL SUPPLY CO.,LTD.
546 58 5519
ma nufa c ture
Revised: 5/2010