TRIADINE PREP - povidone-iodine solution 
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% w/v (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 for longer than 1 week

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, nonoxynol-8, sodium hydroxide, water


LABEL INFORMATION

Cat. No. 10-8204
NDC 50730-8204-4

TRIADINE

POVIDONE-IODINE, USP
PREP SOLUTION
10% Topical Solution

ANTISEPTIC / GERMICIDE

For External Use Only!

4 Fluid Ounces (118 ml)

www.triad-group.net


TRIAD GROUP, INC.
700 West North Shore Drive
Hartland, WI 53029 MADE IN USA



label

TRIADINE PREP 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine.10 mg  in 1 mL
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:50730-8204-3118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33306/21/1985
Labeler - Triad Group (050259597)
Establishment
NameAddressID/FEIBusiness Operations
Triad Group050259597manufacture

Revised: 4/2010
Document Id: 630e7a63-8a73-4af2-95f8-f8049baacb06
Set id: 247ac2c9-0a97-4aa5-85fd-0d75b1b55289
Version: 1
Effective Time: 20100419
 
Triad Group