AMSure Three Povidone-Iodine Swabsticks

Dosage form: swab
Ingredients: Povidone-Iodine 0.1mg in 1mL
Labeler: Amsino International, Inc.
NDC Code: 67752-2003

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.

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

Purpose SectionPurpose 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 SectionUses antiseptic skin preparation

Directions Section

Directions apply locally as needed

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

Questions SectionQuestions?    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   THREE POVIDONE-IODINE SWABSTICKS
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67752-2003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-Iodine (Povidone-Iodine) Povidone-Iodine0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
NONOXYNOL-10 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
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: 02/2012
 
Amsino International, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)