POVIDONE-IODINE PREP SWABSTICK - 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.

----------

DRUG FACTS

ACTIVE INGREDIENT

Povidone Iodine USP 10% w/v (equivalent to 1% 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, Makon 8, purified water, sodium hydroxide


POUCH INFORMATION

TRIAD

Cat. No. 10-4101
NDC 50730-4101-1

10% Povidone Iodine, USP
POVIDONE IODINE
SWABSTICKS (1's)

Antiseptic / Germicide
For Hospital and Professional Use Only

Triad Disposables, Inc.
Brookfield, WI 53045 USA

Contents:
1 Swabstick


foil


CARTON INFORMATION

TRIAD

Cat. No. 10-4101
NDC 50730-4101-1

10% Povidone Iodine, USP
POVIDONE IODINE
SWABSTICKS (1's)

Antiseptic / Germicide
For Hospital and Professional Use Only

Triad Disposables, Inc.
Brookfield, WI 53045 USA

Contents:
50 Pouches
1 Swabstick per Pouch

carton

POVIDONE-IODINE PREP SWABSTICK 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-4101
Route of AdministrationTOPICAL, EPIDURAL, PERCUTANEOUS
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:50730-4101-150 in 1 BOX
11 in 1 POUCH
11.7 mL in 1 APPLICATOR
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)
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: 195f25e7-21ce-4c6d-bedb-b79ceb28b385
Set id: 453bb8f6-3ba3-4a20-b962-5f79d6ab5669
Version: 1
Effective Time: 20091125
 
H and P Industries, Inc. dba Triad Group