APLICARE POVIDONE-IODINE PERINEAL WASH- povidone-iodine perineal wash liquid

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Povidone-iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)

Tilgjengelig fra:

Aplicare, Inc.

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Antiseptic Do not use if allergic to iodine. Do not use in eyes.

Autorisasjon status:

OTC monograph not final

Preparatomtale

APLICARE POVIDONE-IODINE PERINEAL WASH - POVIDONE-IODINE PERINEAL WASH
LIQUID
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
Antiseptic
Stop use and ask a doctor if
infection occurs
redness, irritation, swelling or pain persists or increases
Ask a doctor before use if injuries are
deep puncture wounds
serious burns
Do not use if allergic to iodine.
Do not use in eyes.
Avoid "pooling" beneath patient. Prolonged exposure to wet solution
may cause skin irritation.
Keep out of reach of children. In case of accidental ingestion, seek
professional assistance or consult a
poison control center immediately.
Bottle Label
APLICARE POVIDONE-IODINE PERINEAL WASH
povidone-iodine perineal wash liquid
PRODUCT INFORMATION
Aplicare, Inc.
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5238 0 -18 8 0
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) (Io dine - UNII:9 6 79 TC0
7X4)
Po vido ne -io dine
10 in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
NO NO XYNO L-10 (UNII: K7O76 8 8 7AP)
GLYCERIN (UNII: PDC6 A3C0 OX)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
DIMETHICO NE (UNII: 9 2RU3N3Y1O)
SO DIUM PHO SPHA TE, DIBA SIC ANHYDRO US (UNII: 22ADO53M6 F)
WA TER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:5238 0 -18 8 0 -8
240 g in 1 BOTTLE
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 9 /0 1/19 9 8
LABELER -
Aplicare, Inc. (107255002)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Aplicare, Inc.
0 58 3776 31
ma nufa c ture
Revised: 3/2010