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Triadine Whirlpool

Dosage form: solution
Ingredients: povidone-iodine .10L in 1L
Labeler: H and P Industries, Inc. dba Triad Group
NDC Code: 50730-8428

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,10% (Equivalent to 1% titratable iodine)

PURPOSE

Antiseptic

USES
  • Health-care antiseptic for preparation of the skin prior to surgery
  • First id antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns.

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:
  • apply to the operative site prior to surgery
As a first aid antiseptic
  • 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
  • if bandaged, let dry first


OTHER INFORMATION Store at room temperature 20° - 25° C (68° - 77° F)

INACTIVE INGREDIENTScitric 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)





TRIADINE WHIRLPOOL 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8428
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
povidone-iodine (povidone-iodine) povidone-iodine.10 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate 
glycerin 
sodium hydroxide 
water 
Packaging
#Item CodePackage Description
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/FEIOperations
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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