TRIADINE- 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:

H and P Industries, Inc. dba Triad Group

INN (International Name):

povidone-iodine

Composition:

povidone-iodine .075 mL in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic - Surgical hand scrub for health care professionals - Health Care Antiseptic for preparation of the skin prior to surgery - First Aid 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 - 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 USP 7.5% w/v (equivalent to 0.75% titratable iodine)
PURPOSE
Antiseptic
USES
Surgical hand scrub for health care professionals
Health Care Antiseptic for preparation of the skin prior to surgery
First Aid 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
apply over large areas of the body
use on individuals who are allergic or sensitive to iodine
use as a first aid antiseptic for 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 condition persists for more than 72 hours
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
AS A SURGICAL HAND SCRUB FOR USE BY HEALTH CARE PROFESSIONALS
clean under nails with a nail pick
nails should be maintained with 1 millimeter free edge
wet hands and forearms
apply milliliter (teaspoon) or palmful to hands and forearms
scrub thoroughly paying particular attention to nails, cuticles and
interdigital spaces
rinse and repeat scrub
FOR PREPARATION OF THE SKIN PRIOR TO SURGERY
clean the affected 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 room temperature 15° - 30° C (59° - 86° F)
INACTIVE INGREDIENTS
citric acid, glycerin, nonoxynol-9, PEG-300, sodium hydroxide, sodium
phosphate, water
LABEL INFORMATION
Triadine
Cat. No. 10-8332
NDC 50730-8332-5
POVIDON