Active Ingredient Section
Active ingredient Povidone Iodine USP, 10% W/V (equivaient to 1% tiratable iodine)
Amsure
FDA Label NDC 67752-2003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amsino International, Inc. for the product Amsure (NDC 67752-2003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient section, purpose section, stop use section, warnings section, keep out of reach of children section, indications and uses section, directions section, inactive ingredients section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 ingredientsCitric 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 (Amsino Amsure)
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