TRIADINE WHIRLPOOL - povidone-iodine solution 
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,10% (Equivalent to 1% titratable iodine)

PURPOSE

Antiseptic

USES

WARNINGS

For external use only.

Do not use

  • in the eyes
  • use as a first aid antiseptic for longer than one week
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body

Ask a doctor in case of

  • deep or puncture wounds
  • animal bites
  • serious burns



Stop use and ask a doctor

  • if condition persists or gets worse
  • if irritation and redness develop and persist for over 72 hours.



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 room temperature 20° - 25° C (68° - 77° F)

INACTIVE INGREDIENTS

citric acid, glycerin, nonoxynol-9, sodium hydroxide, water


LABEL INFORMATION

Triad

Cat. No. 10-8428
NDC 50730-8428-6


TRIADINE
POVIDONE-IODINE, USP
WHIRLPOOL CONCENTRATE
10% Solution

Antiseptic / Germicide

For general antiseptic use in Whirlpool or other hydrotherapy tanks.

For External Use Only!


128 Fluid Ounces (3.785 L)


label


TRIADINE WHIRLPOOL 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8428
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine.10 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
sodium hydroxide (UNII: 55X04QC32I)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50730-8428-63.785 L in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33306/21/1985
Labeler - H and P Industries, Inc. dba Triad Group (050259597)
Establishment
NameAddressID/FEIBusiness Operations
H and P Industries, Inc. dba Triad Group050259597manufacture

Revised: 12/2009
Document Id: c9cd53bb-0345-49ba-bc38-3762c6ea8391
Set id: 3f9e9861-91e1-4ef5-a41a-f389c16ebdfb
Version: 1
Effective Time: 20091214
 
H and P Industries, Inc. dba Triad Group