POVIDONE-IODINE SCRUB SWABSTICKS - 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

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

For preparation of the skin prior to surgery As a first aid antiseptic


OTHER INFORMATION

Store at room temperature 15° - 30° C (59° - 86° F)

INACTIVE INGREDIENTS

citric acid, glycerin, purified water, sodium hydroxide, Surfonic N-95


POUCH INFORMATION

TRIAD

Cat. No. 10-4402
NDC 50730-4402-3

7.5% Povidone Iodine, USP
POVIDONE IODINE
SCRUB SWABSTICK (3's)


Triad Disposables, Inc.
Brookfield, WI 53045 USA

Antiseptic / Germicide

For Hospital and Professional Use Only
Contents:
3 Swabsticks




foil


CARTON INFORMATION

TRIAD

Cat. No. 10-4402
NDC 50730-4402-3

7.5% Povidone Iodine, USP
POVIDONE IODINE
SCRUB SWABSTICKS (3's)

Antiseptic / Germicide
For Hospital and Professional Use Only

Triad Disposables, Inc.
Brookfield, WI 53045 USA

Contents:
25 Pouches
3 Swabsticks per Pouch

carton


POVIDONE-IODINE SCRUB SWABSTICKS 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-4402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine.075 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
nonoxynol-9 (UNII: 48Q180SH9T)  
polyethylene glycol 300 (UNII: 5655G9Y8AQ)  
sodium hydroxide (UNII: 55X04QC32I)  
sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50730-4402-325 in 1 BOX
13 in 1 POUCH
11.7 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33301/14/1987
Labeler - H and P Industries, Inc. dba Triad Group (050259597)
Registrant - H and P Industries, Inc. dba Triad Group (050259597)
Establishment
NameAddressID/FEIBusiness Operations
H and P Industries, Inc. dba Triad Group050259597manufacture

Revised: 11/2009
Document Id: 0926eb7c-d18c-4f74-bc07-79e1c0852e89
Set id: c0f14784-60a5-4a13-b8e1-0ac5fc6b4d82
Version: 1
Effective Time: 20091124
 
H and P Industries, Inc. dba Triad Group