POVIDONE IODINE PLUS - povidone-iodine gel 
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.

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DRUG FACTS

ACTIVE INGREDIENT

Povidone Iodine USP 10% (equivalent to 1% titratable iodine)

PURPOSE

Antiseptic

USES

WARNINGS

For external use only.

Do not use

  • in the eyes
  • on individuals who are allergic or sensitive to iodine
  • as a first aid antiseptic longer than 1 week unless directed by a doctor

Ask a doctor in case of

  • deep or puncture wounds
  • animal bites
  • serious burns



Stop use and ask a doctor if

  • irritation and redness develop



Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

For preparation of the skin prior to surgery
As a first aid antiseptic


OTHER INFORMATION

Store at 15° - 30° C (59° - 86° F)

INACTIVE INGREDIENTS

citric acid, glycerin, hydroxyethylcellulose, sodium hydroxide, water


PACKAGE INFORMATION

Cat. No. 11-LP14
NDC 50730-8214-8

TRIAD Plus

POVIDONE IODINE
PREP GEL


Povidone Iodine, USP
10% Topical Gel


4 Fluid Ounces (118 ml)

Triad Group, Inc.
700 West North Shore Drive
Hartland, WI 53029    Made In USA
www.triad-group.net

label




POVIDONE IODINE PLUS 
povidone-iodine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8214
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine0.10 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50730-8214-8118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2001
Labeler - H and P Industries, Inc. dba Triad Group (050259597)
Registrant - H and P Industries, Inc. dba Triad Group (050259597)
Establishment
NameAddressID/FEIBusiness Operations
H and P Industries, Inc. dba Triad Group050259597manufacture

Revised: 4/2010
Document Id: fdf1b647-67ef-48f8-b14a-676ad7cc57e3
Set id: 1948e9d0-bd76-4d69-a032-71639c9e81b9
Version: 4
Effective Time: 20100422
 
H and P Industries, Inc. dba Triad Group