AMSURE  THREE POVIDONE-IODINE SWABSTICKS- povidone-iodine swab 
Amsino International, Inc.

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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Active Ingredient Section

Active ingredient
                                                                                     
Povidone Iodine USP, 10% W/V (equivaient to 1% tiratable iodine)

Purpose Section

Purpose Antiseptic

Stop Use Section

Stop use and ask a doctor if skin irritation, redness, swelling, or pain occurs.

Warnings Section

Warnings • Do not use if allergic to iodine • For external use only • Do not use in eyes • Avoid
pooling beneath patient •  In case of accidental ingestion, seek professional
assistance or consult a poison control center immediately.

Keep Out of Reach of Children Section

Keep out of reach of children.

Indications and Uses Section

Uses antiseptic skin preparation

Directions Section

Directions apply locally as needed

Inactive Ingredients Section

Inactive ingredients
Citric Acid, Glycerol, Nonoxynol-10, Sodium hydroxide, water

Questions Section

Questions?    Call 1-800-632-6746

Other Information Section

Other information

For Hospital or Professional Use Only.

Store at room temperature: 15oC - 30oC

Package Label


AMSINO  AMSure Three Povidone-Iodine Swabsticks  NDC 67752-2003-3  REF  PIS2003

Three 4-inch saturated swabsticks  Sterile, unless opened or damaged  DO NOT RE-USE LATEX-FREE

Distributed by: Amsion International, inc. 855 Towne Center Dr., Pomona, CA 91757, USA  AMSure is a registered trademark of Amsino International, Inc.  Made in China  L5332  Rev. D

Tear open   LOT       EXP.

AMSure Label






AMSURE   THREE POVIDONE-IODINE SWABSTICKS
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67752-2003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-Iodine (UNII: 85H0HZU99M) (Povidone-Iodine - UNII:85H0HZU99M) Povidone-Iodine0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-10 (UNII: K7O76887AP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67752-2003-36 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/06/2012
Labeler - Amsino International, Inc. (825673239)
Registrant - Amsino International, Inc. (825673239)

Revised: 2/2012
Document Id: 9bd269b7-ebe5-4c99-8dd6-3023cdd3f3f0
Set id: d02aec6b-b973-4e88-b42e-adb1ea7a6078
Version: 10
Effective Time: 20120202
 
Amsino International, Inc.