APLICARE POVIDONE-IODINE SCRUB- povidone-iodine solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)

Доступно од:

Aplicare, Inc.

Пут администрације:

TOPICAL

Тип рецептора:

OTC DRUG

Терапеутске индикације:

Antiseptic Do not use if allergic to iodine

Статус ауторизације:

OTC monograph not final

Карактеристике производа

APLICARE POVIDONE-IODINE SCRUB - POVIDONE-IODINE SOLUTION
APLICARE, 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._
----------
DRUG FACTS
Povidone-iodine Scrub Swabstick Packet
Povidone-iodine
Antiseptic
Stop use and ask a doctor if
redness, irritation, swelling or pain persists or increases
infection occurs
injuries are deep or puncture wounds or serious burns
Do not use if allergic to iodine
Keep out of reach of children. In case of accidental ingestion, seek
professional assistance or consult a
poison control center immediately.
Questions or comments?
1 800 760-3236 (Mon to Fri 8:30 AM - 5:00 PM EST)
APLICARE POVIDONE-IODINE SCRUB
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5238 0 -0 0 25
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0
7X4)
POVIDONE-IODINE
8 .1 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)
ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
NO NO XYNO L-9 (UNII: 48 Q18 0 SH9 T)
AMMO NIUM NO NO XYNO L-4 SULFATE (UNII: 9 HIA70 O4J0 )
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:5238 0 -0 0 25-6
2 g in 1 PACKET
2
NDC:5238 0 -0 0 25-9
8 g 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 no t final
pa rt333
0 1/0 1/19 8 4
LABELER -
Aplicare, Inc. (107255002)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Aplicare, Inc.
10 72550 0 2
ma nufa c ture
Aplicare, Inc.
Revised: 1/2010