TRIADINE PREP- povidone-iodine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Triad Group

INN (International Name):

povidone-iodine

Composition:

povidone-iodine .10 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic - 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.

Authorization status:

OTC monograph not final

Summary of Product characteristics

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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Povidone Iodine,10% w/v (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
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:
clean the area
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 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_
ANTISEPTIC for preparation of the skin prior to surgery. Helps reduce
bacteria that potentially can
cause skin infection.
FIRST AID ANTISEPTIC to help prevent the risk of infection in minor
cuts, scrapes and burns.
For Hospital and Professional Use.
_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
TRIADINE PREP
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:50 730 -8 20