POVIDONE IODINE PLUS- povidone-iodine ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M)

Available from:

H and P Industries, Inc. dba Triad Group

INN (International Name):

povidone-iodine

Composition:

povidone-iodine .10 g in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic

Authorization status:

OTC monograph not final

Summary of Product characteristics

POVIDONE IODINE PLUS - POVIDONE-IODINE OINTMENT
H AND P INDUSTRIES, INC. DBA TRIAD GROUP
_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
ACTIVE INGREDIENT
Povidone Iodine USP 10% (equivalent to 1% titratable iodine)
PURPOSE
Antiseptic
USE
First Aid Antiseptic to help prevent infection in minor cuts, scrapes
and burns
WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT USE
in the eyes or over large areas of the body
longer than 1 week unless directed by a doctor
STOP USE AND ASK A DOCTOR
if condition persists or gets worse
in case of deep puncture wounds, animal bites or serious burns
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Clean the affected area. Apply a small amount of this product to the
area 1-3 times daily. May be
covered with a sterile bandage.
OTHER INFORMATION
Store at room temperature 15° - 30° C (59° - 86° F)
INACTIVE INGREDIENTS
glycerin, PEG-300, PEG-1450, propylene glycol
PACKAGE INFORMATION
TRIAD
Cat. No. 11-OP01
NDC 50730-8201-8
POVIDONE IODINE
OINTMENT
10% Povidone Iodine, USP
(equivalent to 1% titratable iodine)_ _
First Aid Antiseptic
For Hospital and Professional Use Only
Triad Group, Inc.
300 West North Shore Drive
Hartland, WI 53029
www.triad-group.net
Net Wt. 1 gram
POVIDONE IODINE PLUS
povidone-iodine ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:50 730 -8 20 1
H and P Industries, Inc. dba Triad Group
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
.10 g in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
G LYCERIN (UNII: PDC6 A3C0 OX)
PO LYETHYLENE G LYCO L 3 0 0 (UNII: 56 55G9 Y8 AQ)
PO LYETHYLENE G LYCO L 14 50 (UNII: OJ4Z5Z32L4)
PRO PYLE