AMSURE THREE POVIDONE-IODINE SWABSTICKS- povidone-iodine swab

AMSure by

Drug Labeling and Warnings

AMSure by is a Otc medication manufactured, distributed, or labeled by Amsino International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

AMSURE   THREE POVIDONE-IODINE SWABSTICKS
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67752-2003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Povidone-Iodine (UNII: 85H0HZU99M) (Povidone-Iodine - UNII:85H0HZU99M)	Povidone-Iodine	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-10 (UNII: K7O76887AP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67752-2003-3	6 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/06/2012

Labeler - Amsino International, Inc. (825673239)

Registrant - Amsino International, Inc. (825673239)