POVIDONE-IODINE - povidone-iodine solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Povidone-Iodine (UNII: 85H0HZU99M) (Povidone-Iodine - UNII:85H0HZU99M)

Tilgjengelig fra:

Smiths Medical ASD, INC

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Antiseptic skin preparation Antiseptic

Autorisasjon status:

OTC monograph not final

Preparatomtale

POVIDONE-IODINE - POVIDONE-IODINE SOLUTION
SMITHS MEDICAL ASD, 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
In case of accidental ingestion, seek professional assistance or
consult a poison control center
immediately.
Antiseptic skin preparation
Do not use if allergic to iodine
For external use only
Ask a doctor before use if injuries are
deep or punture wounds
serious burns
Stop use and ask a doctor if
redness, irritation, swelling or pain persists or increases
infection occurs
Do not use in eyes
Avoid pooling beneath patient
Keep out of reach of children
In case of accidental ingestion, seek professional assistance or
consult a poison
control center immediately.
Apply locally as needed
citric acid, disodium phosphate,
nonoxynol-9, sodium hydroxide, water
Povidone Packet image.jpg
Smiths Medical ASD, INC
Antiseptic
POVIDONE-IODINE
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:516 8 8 -5473
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) (Po vido ne-Io dine - UNII:8
5H0 HZU9 9 M)
Po vido ne -Io dine
9 .8 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CITRIC ACID MO NO HYDRA TE (UNII: 29 6 8 PHW8 QP)
SO DIUM PHO SPHA TE, DIBASIC (UNII: GR6 8 6 LBA74)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
NO NO XYNO L-9 (UNII: 48 Q18 0 SH9 T)
WA TER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:516 8 8 -5473-2
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 rt333A
0 1/0 3/19 8 4
LABELER -
Smiths Medical ASD, INC (137835299)
Revised: 7/2010